    [House Report 108-147]
    [From the U.S. Government Publishing Office]

    108th Congress                                            Rept. 108-147
                            HOUSE OF REPRESENTATIVES
     1st Session                                                     Part 1

    ======================================================================

                         PROJECT BIOSHIELD ACT OF 2003

                                    _______

                     June 10, 2003.--Ordered to be printed

                                    _______

     Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
                                   following

                                  R E P O R T

                            [To accompany H.R. 2122]

          [Including cost estimate of the Congressional Budget Office]

        The Committee on Energy and Commerce, to whom was referred
    the bill (H.R. 2122) to enhance research, development,
    procurement, and use of biomedical countermeasures to respond
    to public health threats affecting national security, and for
    other purposes, having considered the same, report favorably
    thereon without amendment and recommend that the bill do pass.

                                    CONTENTS

                                                                       Page
    Purpose and Summary..............................................     1
    Background and Need for Legislation..............................     2
    Hearings.........................................................     2
    Committee Consideration..........................................     3
    Committee Votes..................................................     3
    Committee Oversight Findings.....................................     3
    Statement of General Performance Goals and Objectives............     3
    New Budget Authority, Entitlement Authority, and Tax Expenditures     3
    Committee Cost Estimate..........................................     3
    Congressional Budget Office Estimate.............................     3
    Federal Mandates Statement.......................................    13
    Advisory Committee Statement.....................................    13
    Constitutional Authority Statement...............................    13
    Applicability to Legislative Branch..............................    13
    Section-by-Section Analysis of the Legislation...................    13
    Committee Correspondence.........................................    20
    Changes in Existing Law Made by the Bill, as Reported............    21

                              Purpose and Summary

        The purpose of the Project BioShield Act of 2003 is to
    provide the Secretary of Health and Human Services with greater
    authority and flexibility to facilitate the research and
    development of biomedical countermeasures; to authorize the
    appropriation of funding for the procurement of security
    countermeasures through the creation of a special reserve fund;
    and to authorize the emergency use of unapproved drugs,
    devices, and biologics and the emergency unapproved use of
    approved drugs, devices, and biologics.

                      Background and Need for Legislation

        During times of nation, military, or public health
    emergency, the American people may be placed at risk of
    exposure to biological, chemical, radiological, or nuclear
    agents, and the diseases caused by such agents. Unfortunately,
    there may not be approved or available countermeasures to treat
    diseases or conditions caused by such agents. Currently,
    companies have little incentive to research, develop, or
    produce vaccines or other drugs simply for a possible one-time
    purchase by the Federal government for the Strategic National
    Stockpile. Most current private sector research and development
    dollars go for drugs or devices that will have continuous
    commercial application. In addition, some of the current
    generation of drugs or devices may have special uses as
    countermeasures to biological agents like Ebola, but there is
    little incentive to perform the research or development or
    production activities that might tailor the drug or drug
    approvals for such a purpose.
        Even if a product has been developed to treat such diseases
    or conditions, if the product has not yet been approved by the
    Food and Drug Administration (FDA), access to the therapy is
    greatly limited. Nothing in the Food and Drug Act allows the
    Secretary to suspend the approval requirements to ensure access
    to unapproved drugs and devices on a large-scale basis in times
    of emergency.
        Under present law, if a product is not approved by the FDA,
    then it is unlawful to provide that product to an individual,
    unless the product has been authorized for distribution under
    an investigational new drug (IND) application (for a drug and
    biologic) or an investigational device exemption (IDE). When a
    drug or device is available under such procedures, a number of
    conditions apply that make the use of an IND or IDE infeasible
    in times of national emergency, where drugs and devices may
    need to be deployed at rapid rates. Even if a drug, biologic,
    or device is highly promising in treating a disease or
    condition associated with biological chemical radiological or
    nuclear agents, and even if it is the only therapy available,
    current FDA law does not allow for rapid deployment of the
    product.
        The Project Bioshield Act is designed to help resolve these
    problems and make our nation more secure. Like the Public
    Health Security and Bioterrorism Preparedness and Response Act,
    the project Bioshield Act is designed to help the
    administration and the nation in public health emergency
    preparedness, but relies on the ingenuity and hard work of
    Americans in the private and public sector to achieve these
    goals.

                                    Hearings

        The Subcommittee on Health held a joint hearing with the
    Subcommittee on Emergency Preparedness and Response of the
    Select Committee on Homeland Security on ``Furthering Public
    Health Security: Project Bioshield'' on March 27, 2003. The
    Subcommittee received testimony from: The Honorable Tommy
    Thompson, Secretary, U.S. Department of Health and Human
    Services; Mr. Leighton Read M.D., General Partner, Alloy
    Ventures, on behalf of Biotechnology Industry Organization; Mr.
    Michael Friedman M.D., Chief Medical Officer for Biomedical
    Preparedness, PhRMA; Mr. James Baker Jr., Ruth Dow Doan
    Professor, Center for Biological Nanotechnology; and, Mr. Gary
    Noble M.D., Vice President of Medical and Public Affairs,
    Johnson & Johnson, on behalf of AdvaMed.

                            Committee Consideration

        On Thursday, May 15, 2003, the Full Committee met in open
    markup session and ordered a Committee Print reported to the
    House, as amended, by voice vote. A request by Mr. Tauzin to
    allow a report to be filed on a bill to be introduced by Mr.
    Tauzin, and that the actions of the Committee be deemed as
    actions on that bill, was agreed to by unanimous consent.

                                Committee Votes

        Clause 3(b) of rule XIII of the Rules of the House of
    Representatives requires the Committee to list the record votes
    on the motion to report legislation and amendments thereto.
    There were no record votes taken in connection with ordering
    the Committee Print reported. A motion by Mr. Tauzin to order
    the Committee Print reported to the House, as amended, was
    agreed to by a voice vote.

                          Committee Oversight Findings

        Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
    House of Representatives, the Committee has held oversight
    hearings and made findings that are reflected in this report.

             Statement of General Performance Goals and Objectives

        The purpose of the Project BioShield Act of 2003 is to
    provide the Secretary of Health and Human Services with greater
    authority and flexibility to facilitate the research and
    development of biomedical countermeasures.

       New Budget Authority, Entitlement Authority, and Tax Expenditures

        In compliance with clause 3(c)(2) of rule XIII of the Rules
    of the House of Representatives, the Committee finds that H.R.
    2212, the Project Bioshield Act of 2003, would result in no new
    or increased budget authority, entitlement authority, or tax
    expenditures or revenues.

                            Committee Cost Estimate

        The Committee adopts as its own the cost estimate prepared
    by the Director of the Congressional Budget Office pursuant to
    section 402 of the Congressional Budget Act of 1974.

                      Congressional Budget Office Estimate

        Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
    House of Representatives, the following is the cost estimate
    provided by the Congressional Budget Office pursuant to section
    402 of the Congressional Budget Act of 1974:

                                         U.S. Congress,
                                   Congressional Budget Office,
                                          Washington, DC, June 6, 2003.
    Hon. W. J. ``Billy'' Tauzin,
    Chairman, Committee on Energy and Commerce,
    House of Representatives, Washington, DC.
        Dear Mr. Chairman: The Congressional Budget Office has
    prepared the enclosed cost estimate for H.R. 2122, the Project
    BioShield Act of 2003.
        If you wish further details on this estimate, we will be
    pleased to provide them. The CBO staff contacts are Jeanne De
    Sa and Sam Papenfuss.
                Sincerely,
                                           Douglas Holtz-Eakin,
                                                              Director.
        Enclosure.

    H.R. 2122--Project BioShield Act of 2003

        Summary: H.R. 2122 would amend the Public Health Service
    Act (PHSA) to authorize appropriations of up to $5.6 billion
    for fiscal year 2004 through 2013 for procurement of certain
    security countermeasures (drugs, devices, and biological
    products to treat, identify, and prevent the public health
    consequences of terrorism). Of that amount, $890 million could
    be obligated in fiscal year 2004 and up to $3.4 billion could
    be obligated during fiscal year 2004 through 2008. Funding to
    buy these security countermeasures would be provided to the
    Department of Homeland Security (DHS), but the Department of
    Health and Human Services (HHS) would be responsible for
    procuring and stockpiling the countermeasures.
        Assuming appropriation of authorized amount and including
    administrative costs, CBO estimates that implementing H.R. 2122
    would increase discretionary spending by $0.3 billion in 2004,
    $3.1 billion for fiscal years 2004 through 2008, and $5.6
    billion over the 2004-2013 period. In addition, H.R. 2122 would
    relax certain requirements for federal agencies related to the
    development and approval of countermeasures. The bill would
    provide HHS with increased authority and flexibility to award
    contracts and grants for research and development of qualified
    countermeasures, hire technical experts, and procure items
    necessary for research. Those provisions might result in higher
    discretionary spending, but CBO does not have sufficient
    information to estimate their budgetary effect.
        The bill also would authorize the Food and Drug
    Administration (FDA) to approve the use of certain security
    countermeasures during emergencies designated by the Secretary
    of HHS. CBO estimates this provision would have no budgetary
    effect.
        H.R. 2122 contains no intergovernmental or private-sector
    mandates as defined in the Unfunded Mandates Reform Act (UMRA)
    and would impose no costs on state, local, or tribal
    governments.
        Estimated Cost to the Federal Government: The estimated
    budgetary impact of H.R. 2122 is shown in the following table.
    The costs of this legislation fall within budget function 550
    (health). CBO assumes that H.R. 2112 would be enacted by
    October 1, 2003.

    ----------------------------------------------------------------------------------------------------------------
                                                            By fiscal year, in millions of dollars--
                                           -------------------------------------------------------------------------
                                             2004    2005    2006   2007   2008    2009    2010   2011   2012   2013
    ----------------------------------------------------------------------------------------------------------------
                                            CHANGES IN DISCRETIONARY SPENDING

    Project BioShield:
        Estimated Authorization Level.....    890    2,528      0      0      0    2,175      0      0      0      0
        Estimated Outlays.................    270      680    870    770    510      440    560    650    490    250
    Administrative Costs:
        Estimated Authorization Level.....      9        9      9      9     10       10     10     10     11     11
        Estimated Outlays.................      7        8      9      9     10       10     10     10     11     11
    ----------------------------------------------------------------------------------------------------------------

    Basis of estimate

        CBO assumes that this bill will be enacted during fiscal
    year 2003 and will take effect in October 2003.
                Procurement of security countermeasures: Project BioShield
        Under current law, HHS administers the Strategic National
    Stockpile (SNS), which contains drugs, diagnostic devices,
    vaccines, and other biological products to combat the public
    health consequences of a terrorist attack or other public
    health emergencies. DHS currently provides the financing for
    those efforts, which include the procurement of a new smallpox
    vaccine and stockpiling of that vaccine and older versions of
    the vaccine. Authorization for those programs was established
    in the Public Health Security and Bioterrorism Preparedness
    Response Act of 2002 (Public Law 107-88). That act authorized
    appropriations of $640 million in 2002 and such sums as may be
    necessary for fiscal years 2003 through 2006 for the SNS and
    $509 million in 2002 and such sums as may be necessary for
    fiscal years 2003 and 2006 for the development of the smallpox
    vaccine. About $400 million was appropriated in 2003 for those
    activities.
        H.R. 2122 would modify the existing authorizations for the
    SNS and for the development of the smallpox vaccine by
    codifying the provision in the PHSA instead of in Public Law
    107-88. CBO estimates that this modification would have no
    budgetary effect.
        H.R. 2122 also would authorize DHS to augment the SNS with
    certain additional products. That effort, called Project
    BioShield, would allow the federal government to enter into
    contracts to procure security countermeasures, which are
    defined in the bill as drugs, devices, biological products,
    vaccines, vaccine adjuvants, antivirals, or diagnostic tests
    used to treat, identify, or prevent harm from an agent that the
    Secretary determines may cause a public health emergency
    affecting national security. Such drugs, devices, or biological
    products would have to be licensed or approved by the FDA, or
    otherwise determined by the Secretary of HHS to have the
    potential to be licensed or approval by the FDA. The federal
    government also could acquire products used to treat the
    adverse effects of drugs or biologic products used as security
    countermeasures.
        The rate at which the funding authorized by the bill would
    be appropriated and spent would depend upon many factors,
    including the nature of advances in biotechnology, the degree
    of industry interest and capacity, the threat environment, and
    government priorities. Assuming appropriation of the authorized
    amounts, current and future Administrations would have the
    discretion to enter into multiple contracts for the manufacture
    of security countermeasures or to cease contracting altogether
    for a period of years.
        To estimate spending under H.R. 2122, CBO consulted with
    Administration officials about activities they are planning or
    would consider if Project BioShield were enacted. Officials
    described plans to acquire and maintain stockpiles of seven
    security countermeasures to combat five biological agents. The
    Administration estimates that the cost of procuring, storing,
    and replacing those countermeasures would be about $5.6 billion
    over the 2004-2013 period if there were no constraints on
    funding.
        Those currently planned acquisitions do not include any
    countermeasures for chemical, radiological, or nuclear agents,
    and they address only a subset of the threats for which
    research and development activities on countermeasures is being
    conducted or funded by HHS, the Department of Defense (DoD),
    and the private sector. Based on information provided by
    government officials and in consultation with outside experts,
    CBO has concluded that it is likely that drugs, devices, or
    biological products addressing some of those other threats will
    be developed in the coming decade and that some of those
    countermeasures would be stockpiled under Project Bioshield if
    funds were appropriated for that purpose. CBO's estimate does
    not assume that any specific product would be developed and
    procured at any specific time. It does, however, account for a
    range of possibilities that would be available to the
    government if the authorized funds are appropriated.
        Authorities and Requirements Under H.R. 2122. H.R. 2122
    would authorize appropriations of up to $5.6 billion for fiscal
    years 2004 through 2013 for the federal government to enter
    into contracts to procure security countermeasures. Of that
    amount, $890 million could be obligated in fiscal year 2004 and
    up to $3.4 billion could be obligated during fiscal years 2004
    through 2008.
        Decisions regarding what types of security countermeasures
    to procure would be made by the President after reviewing
    recommendations of the Secretaries of DHS and HHS. Subject to
    Presidential approval and a determination that inclusion of
    certain countermeasures in the stockpile is appropriate, the
    Secretaries of DHS and HHS would seek potential vendors to
    produce the countermeasures and enter into contracts to buy the
    countermeasures from those vendors. In making that
    determination, the Secretary would determine and consider
    several factors, including the quantity of the product
    necessary for the stockpile, the feasibility of obtaining
    sufficient quantities of the product within five years, and
    whether there is a significant commercial market for the
    product other than as a security countermeasure. Those factors
    would not be requirements for procurement, but considerations
    in determining the appropriateness for inclusion of the
    countermeasure in the stockpile.
        The Secretary of HHS would be responsible for arranging the
    procurement, including negotiating the quantity, price, and
    production schedule in five-year contracts or cooperative
    agreements, though eight-year contracts would be permitted for
    first awards. Payment would be conditioned on the delivery of a
    substantial portion of promised units. However, the Secretary
    could provide an advance payment of not to exceed 10 percent of
    the contract if the Secretary determines such payment is
    necessary to the project's success. The Secretary could pay
    vendors for storage, shipping, and handling and would be
    permitted to use noncompetitive procedures if the product is
    available only from a limited number of sources. Additional
    countermeasures for the same threat also could be procured, if
    they were to provide improved safety or effectiveness or
    otherwise enhance public health preparedness.
        The authorized funds could not be used for the purchase of
    vaccines under contracts entered into prior to enactment, or
    for administrative costs. Based on information from
    Administration officials, CBO expects that funding would not be
    available specifically for research and development, although
    the price for the completed products would probably cover some
    development costs.
        The Administration's Plans to Implement Project BioShield.
    Based on existing science and a current assessment of potential
    threats to public health, the Administration has identified
    several agents for which countermeasures are needed to protect
    the public health and could be included in Project BioShield.
    Those agents are smallpox, anthrax, botulinum toxin, plague,
    and Ebola. The Administration estimates that spending for
    countermeasures under Project BioShield, including purchase,
    storage, and replacement costs, would total about $5.6 billion
    over the 2004-2013 period, assuming the successful development
    of those countermeasures and no constraints on funding. More
    than half of those costs would be for the improved smallpox and
    anthrax vaccines. A brief description follows of the security
    countermeasures the Administration plans to acquire and
    stockpile.
        Smallpox. Under Project BioShield, the Administration plans
    to procure a next-generation version of the smallpox vaccine
    called modified vaccinia Ankara (MVA). This new vaccine is an
    attenuated version of the existing vaccine and may be used to
    safely vaccinate about 30 million individuals with compromised
    immune systems, eczema, or certain other high-risk conditions.
    Under the authority provided for Project BioShield, HHS plans
    to purchase 60 million doses of the new vaccine at about $15
    per dose over a three-year period for a cost of about $900
    million. The Administration expects to be able to enter into
    contracts and begin acquiring the vaccine in 2004. Additional
    costs for inventory management and replacement of expired
    stocks over the 2007-2013 period would likely add another $1
    billion, according to Administration estimates, but could be
    lower if long-term refrigerated storage proves to be effective.
        Anthrax. The Administration also expects to purchase about
    60 million doses of a next-generation anthrax vaccine, called a
    recombinant protective antigent (rPA) vaccine, under Project
    BioShield. The rPA vaccine would require fewer doses per person
    than the current vaccine, and potentially could be effective
    for people who have already been exposed to anthrax, giving the
    government the ability to vaccinate about 20 million people.
    The Administration anticipates beginning the procurement
    process in the next few years and spending about $700 million
    on the vaccine over a three-year period. Because the rPA
    anthrax vaccine has an expected shelf life of five to six
    years, additional costs would be incurred for inventory
    management and replacement. The Administration estimates that
    costs for the rPA vaccine could total $1.4 billion over the
    2004-2013 period.
        Botulinum Toxin. Under current law, HHS has stockpiled some
    antitoxins to treat botulism, a paralytic and often fatal
    illness caused by a nerve toxin produced by the botulinum
    bacteria. However, those antitoxins are no longer manufactured,
    and the manufacturing process, which requires horse serum, is
    complicated and time intensive. After identifying a
    manufacturer, the Administration plans to spend about $800
    million acquiring newly produced antitoxin at a cost of about
    $2,000 per dose as part of Project BioShield. Acquisition would
    be spread over a three-year period, beginning in the next few
    years. This antitoxin would require specialized storage and
    refrigeration.
        In addition, the Administration has indicated that it would
    like to purchase both a vaccine that would protect against
    botulism and monoclonal antibodies to neutralize the effects
    ofthe toxin. (Monoclonal antibodies are engineered proteins that can
    neutralize and destroy certain pathogens and toxins.) The
    Administration anticipates buying vaccine and monoclonal antibodies by
    2007 or 2008, at a cost of about $140 million for 750,000 doses of the
    vaccine and $750 million for monoclonal antibodies. The Administration
    estimates that spending for botulinum countermeasures, including the
    cost of storage and inventory management, would total $1.8 billion over
    the 2004-2013 period.
        Plague. Plague is an infectious disease caused by a
    bacterium. Plague has several forms--pneumonic, bubonic, and
    septicemic--and can be treated by existing antibiotics. A
    vaccine for the plague is currently in the research and
    development phase, with the expectation that a product
    potentially could reach the advanced development phase next
    year. Beginning in 2005, the Administration expects to procure
    about 2 million doses (enough to treat people in areas
    surrounding any outbreak) at an estimated cost of about $40 per
    dose--for a total cost of about $80 million. With additional
    costs related to the acquisition of the vaccine, the
    Administration estimates spending on plague countermeasures
    would total about $220 million over the 2004-2013 period.
        Ebola. There is no current treatment for Ebola, one of
    several viral hemorrhagic fevers, but the National Institutes
    of Health (NIH) is conducting research on a vaccine that the
    Administration would be interested in purchasing when it
    reaches an advanced development stage. Under current plans, the
    Administration intends to purchase enough vaccine for 3 million
    individuals to prevent the spread of an outbreak. Because this
    vaccine is still in the research and development phase, when
    the vaccine would become available and the potential cost per
    dose are unclear. The Administration assumes the vaccine will
    become available in 2005, and estimates the price to be about
    $30 per dose, for a total acquisition cost of $90 million.
    Combined with other costs related to the Ebola vaccine,
    including storage and replacement, the Administration
    anticipates spending would total about $260 million over the
    2004-2013 period for this aspect of Project BioShield.
        CBO's Estimate of the Potential Cost of Project BioShield.
    CBO has estimated both the cost of implementing the
    Administration's plan and the potential cost of acquiring other
    products not encompassed by that plan.
        CBO's Estimate of the Administration's Plan. Without any
    funding constraints, CBO expects that the Administration's
    plans for MVA smallpox vaccine, the anthrax rPA vaccine, and
    the botulism antitoxins would likely take shape as described,
    albeit more slowly than the Administration estimates. CBO
    estimates that spending for vaccines and monoclonal antibodies
    for botulism and vaccines for plague and Ebola would likely be
    lower than the Administration estimates, even without funding
    constraints. CBO's lower estimate reflects the possibility that
    development of those vaccines and monoclonal antibodies might
    not succeed as quickly as the Administration's estimate
    assumes. It also reflects the possibility that Project
    BioShield would spend less on some of the botulism
    countermeasures if all three countermeasures (vaccine,
    antitoxins, and monoclonal antibodies) became available.
        CBO estimates that about $5.2 billion would be required to
    procure products identified by the Administration over the
    2004-2013 period.
        Estimated Spending for Products Not Listed in the
    Administration's Plan. Under the bill, other countermeasures
    not in the Administration's plan could be purchased with
    appropriations provided through Project BioShield.
    Consequently, the specific security countermeasures that would
    be acquired under H.R. 2122 are likely to evolve over time as
    the result of many factors, including scientific advances, the
    interest and cooperation of biotech and other manufacturing
    companies, the emergence of new threats, and changes in this
    and future Administrations' assessments of which potential
    countermeasures should be a priority. Barriers to technological
    advance such as restricted laboratory space or shortage of
    primates for testing could slow development of countermeasures
    for certain agents. At the same time, rapid advances in
    products currently in the early-stage research and development
    could present the government with unforseen countermeasure
    options. Acquisition of countermeasures would also be affected
    by whether this and future Administrations decide to procure
    products that require more than five years to be licensed or
    have a significant commercial market.
        Acquisitions under the bill might include additional
    countermeasures for agents addressed by the Administration's
    plan. For instance, potential emerging treatments include the
    use of monoclonal antibodies. This technology has had initial
    application in the treatment of cancer, and possibly could be
    applied to anthrax, the plague, or viral hemorrhagic fevers in
    the coming years. Other potential countermeasures include new
    antiviral drugs to treat smallpox and viral hemorrhagic fever
    (both biodefense research priorities for NIH) and a narrow-
    spectrum antibiotic for anthrax.
        In addition, CBO's research indicates there are numerous
    other biological agents for which countermeasures ultimately
    could be purchased under Project BioShield. HHS has established
    three classes of biological agents that pose significant risks
    to national security and the public health. Category A agents
    pose the greatest risk due to their ease of transmission,
    mortality rates, and overall risk to the public. All of the
    agents included in the Administration's plan are considered
    Category A agents, but that initial plan does not address such
    Category A agents as tularemia, a bacterial infection affecting
    the respiratory system, and viral hemorrhagic fevers other than
    Ebola. Vaccines for both of those agents arebiodefense research
    priorities of NIH. Further, the government might seek countermeasures
    for some Category B and C agents, including toxins such as ricin,
    certain bacteria such as brucellosis, and several forms of viral
    encephalitis.
        Also, under the authority provided by the bill, the
    government could procure countermeasures against chemical
    agents (nerve, blister, blood, and pulmonary agents) and
    radiological and nuclear agents. The Administration currently
    does not plan to use the bill's authority to purchase agents
    that could mitigate threats from these sources, but it could do
    so if the perceived threat from these agents changed or if
    certain treatments became scientifically feasible.
    Countermeasures that could be acquired under Project BioShield
    include existing treatments for many nerve gases (including VX,
    Sarin, and Soman gas), Prussian Blue (a treatment for certain
    types of radiation poisoning), and hydroxycobalamin (a
    treatment for cyanide poisoning that is in an advanced stage of
    development).
        Finally, under H.R. 2122, Project BioShield would be able
    to purchase devices to detect and diagnose pathogens and other
    agents. Costs for such devices are also not included in the
    Administration's estimate.
        To estimate potential spending for additional
    countermeasures not mentioned in the Administration's plan, CBO
    identified several category A, B, and C biological agents and
    chemical and radiological agents for which countermeasures
    exist or are under development. The set of selected agents and
    countermeasures is not intended as a prediction of which
    countermeasures would be acquired by Project BioShield. Rather,
    it is intended to be representative of the countermeasures that
    would be eligible for acquisition if current research and
    development activities succeed in producing qualified
    countermeasures during the coming decade.
        For each of the representative biological agents, CBO
    determined whether the countermeasure is likely to be a
    vaccine, an antitoxin or antiviral, or a monoclonal antibody,
    the dosage and method of delivery (intravenously or in pill
    form), and the amount necessary to treat the population that
    could potentially be affected. the estimate assumes that
    vaccines would cost $30 to $40 per dose, on average, with
    Project BioShield acquiring 500,000 to 2 million doses of
    qualified vaccines, depending on whether the agent is
    infectious. CBO estimates that monoclonal antibodies would cost
    $5,000 per treatment, and that Project BioShield would acquire
    enough to treat several hundred thousand people if qualified
    products became available. The estimate assumes that, if other
    types of qualified antivirals or antitoxins became available,
    Project BioShield would acquire enough to treat 500,000 people,
    at costs ranging from $2,000 to $5,000 per person for certain
    intravenously-administered forms. Other countermeasures could
    be less expensive on a per-person basis. For example, certain
    antivirals or narrow-spectrum antibiotics in pill form could
    cost about $100 per treatment, CBO estimates. Additionally, CBO
    estimates that per-person costs would average $50 for Prussian
    Blue, $100 for intravenous treatments for hydrogen cyanide, and
    $300 per treatment for countermeasures for certain radiological
    and nuclear agents. If Project BioShield acquired those types
    of countermeasures, CBO assumes that the quantity procured
    would be sufficient to respond to simultaneous events in
    several large cities.
        Under optimistic assumptions about when countermeasures for
    the representative agents would become available, the cost of
    acquiring, storing, and replacing all qualified countermeasures
    for those agents could total $10 billion to $20 billion during
    the 2004-2013 period. However, CBO assumes that research and
    development efforts for some countermeasures will proceed
    slowly or be unsuccessful, and that the Administration would
    not acquire all products that could be designated as security
    countermeasures.
        Assuming appropriation of the authorized amount, CBO
    estimates that discretionary spending to acquire and store
    BioShield products would total $0.3 billion in 2004 and $5.5
    billion over the 2004-2013 period. Acquisition costs would
    comprise 70 percent to 80 percent of that amount, while
    inventory management and replacement costs would make up the
    balance.
        CBO also estimates that implementing Project BioShield
    would add to the administrative costs of HHS and DHS, both for
    the contracting process and managing the stockpile. Funding for
    those costs would come from appropriated funds. Based on
    current spending for program support services for bioterrorism-
    related activities (including the SNS) at the Centers for
    Disease Control and Prevention, CBO estimates that
    administrative costs would be about $10 million a year. Subject
    to the appropriation of necessary amounts, CBO estimates that
    discretionary spending for such costs would increase by $7
    million in 2004 and $0.1 billion over the 2004-2013 period.
                Research and development into qualified countermeasures
        H.R. 2122 would authorize the Secretary of HHS to expedite
    procurement and peer review for research related to qualified
    countermeasures. The bill also would allow the Secretary to
    secure the services of experts or consultants with relevant
    expertise. Implementation of these measures could increase the
    resources required by the agency, accelerate spending, or both.
    CBO does not have sufficient information to estimate the
    additional resources that might be required by the agency or
    the rate at which spending might accelerate under the bill.
    Such spending would come from appropriated funds.
                Authorization for medical products for use in emergencies
        The FDA's regulatory process allows for expedited approval
    of security countermeasures under current law. Pursuant to the
    Public Health Security and Bioterrorism Preparedness and
    Response Act of 2002, the FDA may allow certain drugs, devices,
    and biologics defined as priority countermeasures to move more
    quickly through the agency's regulatory process. To further
    expedite the development of security countermeasures, the FDA
    has implemented a rule that allows approval of certain drugs
    based on tests in animals.
        H.R. 2122 would allow the Secretary of HHS to authorize the
    FDA to approve the use of certain drugs or devices for use
    during designated as emergencies by the Secretary of HHS, DHS,
    or Defense. The authorization would remain in effect for no
    more than one year, unless the Secretary determines otherwise
    based on the nature of the emergency. When the Secretary
    authorizes the emergency use of a product that is an unapproved
    use of an approved product, the bill would provide some
    flexibility to manufacturers in carrying out activities under
    the emergency use authorization.
        Based on information from Administration officials, CBO
    expects that implementing this provision in H.R. 2122 would not
    increase costs to the FDA. Over the past year, the FDA has
    hired about 100 people to review drug applications and provide
    assistance to companies engaged in research and development
    into security countermeasures. Thus, the agency already has the
    infrastructure to handle the additional authority related to
    the proposed emergency-use authorization and would not require
    additional resources. Therefore, CBO estimates that this
    provision of H.R. 2122 would have no budgetary effect.
        Previous CBO estimate: S. 15, the Project BioShield Act of
    2003, as reported by the Senate Committee on Health, Education,
    Labor and Pensions on March 25, 2003, would amend the Public
    Health Service Act (PHSA) to create permanent, indefinite
    funding authority for the procurement of certain biomedical
    countermeasures. In its cost estimate dated May 7, 2003, CBO
    estimated that enacting S. 15 would increase direct spending by
    $270 million in 2004 and $8.1 billion over the 2004-2013
    period.
        Although both H.R. 2122 and S. 15 would authorize programs
    to procure countermeasures to protect the public health against
    terrorism, H.R. 2122 would not have an effect on direct
    spending; instead, the bill would authorize appropriations of
    up to $5.6 billion over the 2004-2013 period. Estimated
    spending under H.R. 2122 is less than under S. 15 because the
    House bill would authorize a set amount of appropriations,
    whereas the Senate bill would provide unlimited direct spending
    authority.
        In several areas, H.R. 2122 would allow the Secretary more
    flexibility in terms of what products could be procured and how
    contracts would be structured. H.R. 2122 would allow the
    procurement of countermeasures even if they have a significant
    commercial application, while S. 15 would restrict the
    procurement authority to those without such application. While
    S. 15 would require the Secretary to determine that a
    countermeasure is likely to be approved by the FDA within five
    years as a condition of procurement, H.R. 2122 would require
    only that the Secretary consider whether a five-year limit is
    feasible. H.R. 2122 would provide additional flexibility in
    contracting by permitting the Secretary to extend first-time
    contracts to eight years (versus five in S. 15) and would allow
    the Secretary discretion to provide a 10 percent advance to
    companies developing new products. Those provisions would
    accelerate spending relative to S. 15.
        Intergovernmental and private-sector impact: H.R. 2122
    contains no intergovernmental or private-sector mandates as
    defined in UMRA and would impose no costs on state, local, or
    tribal governments.
        Estimate prepared by: Federal costs: Jeanne De Sa and Sam
    Papenfuss: impact on state, local, and tribal governments: Leo
    Lex; impact on the private sector: Samuel Kina.
        Estimate approved by: Robert A. Sunshine, Assistant
    Director for Budget Analysis.

                           Federal Mandates Statement

        The Committee adopts as its own estimate of Federal
    mandates prepared by the Director of the Congressional Budget
    Office pursuant to section 423 of the Unfunded Mandates Reform
    Act.

                          Advisory Committee Statement

        No advisory committees within the meaning of section 5(b)
    of the Federal Advisory Committee Act were created by this
    legislation.

                       Constitutional Authority Statement

        Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
    House of Representatives, the Committee finds that the
    Constitutional authority for this legislation is provided in
    Article I, section 8, clause 3, which grants Congress the power
    to regulate commerce with foreign nations, among the several
    States, and with the Indian tribes.

                      Applicability to Legislative Branch

        The Committee finds that the legislation does not relate to
    the terms and conditions of employment or access to public
    services or accommodations within the meaning of section
    102(b)(3) of the Congressional Accountability Act.

                 Section-by-Section Analysis of the Legislation

    Section 1. Short title

        Section 1 establishes the short title of the Act as the
    ``Project BioShield Act of 2003.''

    Section 2. Biomedical countermeasure research and development
            authorities

        Section 2(a) of the Project BioShield Act of 2003 amends
    the Public Health Service Act to add a new section 319F-1. The
    section grants the Secretary of Health and Human Services (HHS)
    additional flexibility and authority in conducting research and
    development with respect to biomedical countermeasures against
    biological, chemical, nuclear and radiological agents that may
    affect national security.
        The Act defines the scope of the new authorities set forth
    in this section as applying to countermeasures against agents
    that ``may cause a public health emergency affecting national
    security.'' In making a determination about whether a potential
    public health emergency could affect national security, the
    Secretary of HHS may consider all information deemed pertinent
    and appropriate, and nothing in this Act requires that such
    Secretary of HHS consult with other executive branch officials
    prior to making such a determination. The Committee expects
    that the Secretary of HHS will consider the threat of use of
    such agents by terrorists against the U.S. population to be a
    significant factor in making scope determinations under these
    provisions. However, the Committee also recognizes and
    encourages the Secretary of HHS to consider the emerging
    threats to public health and national security that may be
    caused by the spread of antibiotic resistant organisms or
    dangerous viruses that may spread rapidly and lack effective
    countermeasures today. These threats may affect national
    security whether by terrorists or through natural conditions.
    The Secretary of HHS should consider such factors in
    determining whether to use these new authorities to promote
    research, development, and production of specific security
    countermeasures.
        Indeed, antimicrobial-resistant infectious microbes are
    viable biological agents that could be used by both domestic
    and foreign terrorists to wreak havoc and injury upon U.S.
    citizens. In addition, the emergency of drug resistance in one
    organism may have the effect of limiting that drug's ability to
    treat other biological agents, as genetic material may be
    transferred naturally or purposefully from one infectious agent
    to another. Advancing the discovery of new antimicrobial drugs
    to treat resistant organisms, through Bioshield and other
    research and development initiatives, through Bioshield and
    other research and development initiatives, may well pay
    dividends for both national security and public health.
        New subsection 319F-1(b) provides general authority.
    Proposed subparagraph 319F-1(a)(4) makes the facilities of
    entities that enter into a grant or cooperative agreement with
    the Secretary of HHS under this section available as needed to
    such Secretary of HHS to respond to public health emergencies
    affecting national security.
        New subsection 319F-1(b) provides expedited authority for
    governmental procurements used to perform, administer, or
    support pressing research and development activities under this
    section, by (1) increasing the simplified acquisition threshold
    from $100,000 to $25 million; (2) authorizing the use of
    procedures providing for less than full and open competition
    when there are only a limited number of responsible sources and
    no other type of services will satisfy the Secretary of HHS
    needs; and (3) increasing the micropurchase threshold for such
    procurements to $15,000.
        New subsection 319F-1(c) authorizes the Secretary of HHS to
    use expedited peer-review procedures in lieu of otherwise
    applicable peer-review procedures in the case of grants and
    contracts for biomedical countermeasure research and
    development activity, if such grants and contracts do not
    exceed $1,500,000 and are necessary to respond to pressing
    research needs.
        New subsection 319F-1(d) provides additional flexibility to
    the Secretary of HHS with respect to the hiring of experts and
    consultants when necessary to respond to pressing qualified
    countermeasure research and development needs. Under paragraph
    319F-1(d)(2), such experts and consultants are deemed to be
    employees of HHS for purposes of the Federal Torts Claims Act,
    which provides the exclusive remedy against such personnel for
    claims relating to the performance of covered duties.
        New subsection 319F-1(e) provides streamlined personnel
    authority for the HHS Secretary to appoint up to 30 people to
    positions in the National Institutes of Health without regard
    to ordinary classificationcriteria, when necessary to respond
    to pressing qualified countermeasure research and development needs.
        New subsection 391F-1(f) provides that actions by the
    Secretary of HHS under the section are committed to agency
    discretion.
        Section 2(b) of the Project BioShield Act of 2003 amends
    section 481A of the Public Health Service act to add the
    Director of the National Institute of Allergy and Infectious
    Diseases to that section, and thus provide to that Director
    certain authorities concerning modernization and construction
    of research facilities. Section 2(b) further authorizes such
    sums as may be necessary for such purposes.

    Section 3. Biomedical countermeasures procurement

        Section 3(a) of the Project BioShield Act of 2003 adds a
    new section 319F-2 to the Public Health Service Act. Several
    provisions of new section 319F-2 simply transfer existing
    provisions of law from the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002, as amended
    by the Homeland Security Act of 2002. Proposed Subsection 319F-
    2(a) contains language from existing law establishing the
    Strategic National Stockpile. New section 319F-2(b) contains
    language from existing law concerning authorizing procurement
    of smallpox vaccine for the National Strategic Stockpile.
        New section 319F-2(c) requires the Secretary of the
    Department of Homeland Security (DHS) to assess threats that
    may be posed by chemical, biological, radiological, and nuclear
    agents, and requires the HHS Secretary to assess the public
    health consequences of such agents and the availability and
    appropriateness of countermeasures for the threats identified.
    After these steps, the Secretaries jointly may determine and
    recommend to the President that funding for procurement of such
    a countermeasure for the nation's stockpile is appropriate from
    the special reserve funds established by this Act.
        Under section 319F-2(c)(4), the Secretaries of HHS and DHS
    may recommend to the President a proposal to issue a call for
    the development of a security countermeasure. Such a call, at a
    minimum, includes a commitment from the Secretaries to make a
    recommendation for funding of such a countermeasure from the
    special reserve funds, if government specifications for the
    product are achieved. The Secretaries also may secure a
    Presidential approval for funding prior to, or without,
    conducting a call.
        New section 319F-2(c)(4)(B) provides that the Secretaries
    should include in any call for proposals for countermeasure
    production information that may be necessary to encourage or
    facilitate research and development into such countermeasures.
    The Committee recognizes that an important factor companies
    will consider in determining whether to invest scarce research
    and development dollars into security countermeasures is
    whether and to what extent they may face liability relating to
    the development or production of such countermeasures. The
    Committee thus encourages the Secretaries to indicate in any
    call for proposals the potential availability of
    indemnification or liability protections under other laws.
        Under section 319F-2(c)(7), if the President approves a
    recommendation for funding from the special reserve funds, DHS
    would then enter into an agreement with HHS under which HHS may
    procure the countermeasure for the stockpile using the DHS
    special reserve fund. Contracts under this paragraph are
    subject to certain conditions. The Secretary of HHS may use
    simplified acquisition procedures or procedures providing for
    less than full and open competition under certain
    circumstances. Certain determinations of the Secretary are
    committed to agency discretion.
        The Committee recognizes that existing procurement
    authorities may allow for a single agreement that provides for
    research and development as well as production of a
    countermeasure or vaccine. Nothing in this Act shall limit the
    use of these existing authorities where a single agreement
    (including a contract, grant, cooperative agreement or other
    acquisition instrument) for research, development, and
    production of a countermeasure or vaccine is deemed appropriate
    by the contracting officer, including when a separate funding
    source is authorized and used for the research and development
    and it is different than the funding source authorized and used
    for production. The Committee recognizes that such agreements
    providing express linkage between research, development, and
    production may be necessary in order to encourage entities to
    enter the government market for countermeasures and vaccines in
    accordance with the authorities provided by Project Bioshield.
    Similarly, existing procurement authorities may allow the
    Secretaries to limit competition for a production contract
    under section 3 of this Act to those entities that successfully
    competed for research and development contracts under section 2
    of this Act or other provisions of law. However, the Committee
    emphasizes that the monies obligated from the special reserve
    fund created under section 3 of this Act may not be use to pay
    for research or development activities, but only for
    procurement of countermeasures paid upon substantial delivery
    of product--consistent with the express limitation contained in
    the Homeland Security Act of 2002 excluding from the DHS
    Secretary's responsibilities the conduct or support of human
    health-related countermeasure research and development.
        Section 319F-2(d) contains prohibitions on disclosure of
    information transferred from existing law. Section 319F-3(e)
    contains definitions transferred from existing law.
        Section 319F-2(f) contains authorization of appropriations
    for the Strategic National Stockpile and smallpox vaccine
    development transferred from existing law with one addition.
    The new paragraph makes clear that such existing authorizations
    are in addition to amounts authorized under the special reserve
    fund. Nothing in the Act would restrict or alter the
    Secretaries' existing authority to purchase items for the
    stockpile using existing discretionary appropriations for such
    purpose.
        Section 3(b) of the Project BioShield Act of 2003 adds a
    new section 510 to the Homeland Security Act of 2002. This new
    section authorizes appropriations for the special reserve fund
    referenced in the new section 319F-2(c) of the Public Health
    Service Act. The bill authorizes $890 million in FY 04 for such
    procurements, and aggregate amounts of $3.4 billion and $5.6
    billion over the next five and ten fiscal yearsrespectively.
    All amounts appropriated under this authorization would be available
    for obligation through the end of FY 2013.
        The act defines the scope of the new authorities set forth
    in this section as applying to countermeasures against agents
    that the Secretary of HHS believes ``may cause a public health
    emergency affecting national security,'' and about which the
    HHS and DHS Secretaries make certain additional findings. In
    making a determination about whether a potential public health
    emergency could affect national security, the Secretary of HHS
    may consider all information deemed pertinent and appropriate,
    and nothing in this Act requires that such Secretary of HHS
    consult with other executive branch officials prior to making
    such a determination. The Committee expects that both
    Secretaries will consider the threat of use of such agents by
    terrorists against the U.S. population to be a significant
    factor in making their respective scope determinations under
    these provisions. However, the Committee also recognizes and
    encourages the Secretaries to consider the emerging threats to
    public health and national security that may be caused by the
    spread of antibiotic resistant organisms or dangerous viruses
    that may spread rapidly and lack effective countermeasures
    today. These threats may affect national security whether by
    terrorists or through natural conditions. The Secretaries
    should consider such factors in determining whether to use
    these new authorities to promote research, development, and
    production of specific security countermeasures.

    Section 4. Authorization for medical products for use in emergencies

        Section 4 adds a new section 564 to the Federal Food, Drug,
    and Cosmetic Act. New section 564(a) allows the Secretary of
    Health and Human Services to authorize for introduction into
    interstate commerce unapproved drugs, devices, and biological
    products or unapproved uses of approved drugs, approved/cleared
    devices, and biological products intended for use in an actual
    or potential emergency during the effective period of a
    declaration.
        New section 564(b) allows the Secretary of HHS to declare
    an emergency justifying an emergency use authorization based
    upon a determination by the Secretary of Homeland Security that
    there is a national emergency or the significant potential of
    one, or by a determination of the Secretary of Defense that
    there is a military emergency, or a significant potential of
    one. Such emergencies must involve a heightened risk of attack
    with biological, chemical, radiological, or nuclear agents.
    Similarly, an emergency use authorization can be based upon a
    determination of the Secretary of HHS that there is a public
    health emergency affecting national security and involving
    biological, chemical, radiological, or nuclear agents. In
    making a determination about whether a public health emergency
    under section 319 of the Public Health Service Act affects
    national security, the Secretary may consider all information
    he deems pertinent and appropriate, and nothing in this Act
    requires that the Secretary consult with other executive branch
    officials prior to making such a determination.
        Under this section, any declaration of emergency will last
    for one year, unless the Secretary of HHS terminates it at an
    earlier time. The Secretary of HHS may renew a declaration. The
    Secretary of HHS must publish all declarations, determinations,
    and renewals in the Federal Register, and the Secretary must
    provide reasonable advanced notice that declarations are to be
    terminated under this section. The Committee intends that,
    after a declaration is terminated, final disposition of
    labeling or intrastate disposition of a product may occur.
    Further, the Committee believes that the Commissioner of the
    Food and Drug Administration may exercise enforcement
    discretion not to object to interstate shipment of an
    unapproved product for return to a manufacturer. A
    determination of what is a ``reasonable'' period for advanced
    notice of termination should consider all factors, so in some
    cases notice immediately preceding termination may be
    reasonable, while in other circumstances it may not.
        Section 564(c) details the criteria for issuance of an
    emergency use authorization. Under this new section, the
    Secretary of HHS, acting through the Commissioner, may issue an
    authorization upon concluding (1) that a biological, chemical,
    radiological, or nuclear agent or agents can cause a serious or
    life-threatening disease or condition; (2) that the drug,
    device or biological product may be effective in detecting,
    diagnosing, treating, or preventing such disease or condition
    (or a serious disease or condition caused by taking a product
    already approved, licensed or cleared by FDA for treating or
    preventing such disease or condition), and the benefits of the
    product outweigh risks; (3) that there is no adequate,
    approved, and available alternative to the product; and (4)
    other criteria the Secretary may by regulation specify. The
    Commissioner should consult with the Directors of the National
    Institutes of Health and the Centers for Disease Control and
    Prevention prior to issuing an authorization, but such
    consultation is limited by considerations of feasibility and
    appropriateness given the circumstances of the emergency.
        Section 564(d) concerns the scope of an emergency use
    authorization. Under this section, the authorization shall
    state the disease or condition that the product may be used to
    detect, diagnose, prevent, or treat, as well as the
    Commissioner's conclusions about known benefits and risks of
    the product and conclusions concerning safety and potential
    effectiveness. The Committee intends that before issuing an
    authorization under this section, the Commissioner will, where
    feasible given the nature and the extent of the emergency,
    notify the holder of any relevant application under this
    chapter or under section 351 of the Public Health Service Act.
    The purpose of such notification is to allow for discussion of
    the conditions of this authorization as required by subsection
    (e), as well as discussion of whether such product should be
    delivered pursuant to section 319F-2(c) of the Public Health
    Service Act.
        Section 564(e) pertains to products that have never been
    approved, licensed, or cleared by FDA. Under this subsection,
    conditions shall, to the extent feasible given the
    circumstances of the emergency, be applied to persons who
    choose to carry out an activity for which the authorization is
    issued. Such mandatory conditions include information to
    providers about the emergency use of the product as well as
    significant knownpotential risks and benefits, as well as
    appropriate conditions designed to ensure that to the maximum extent
    feasible given the circumstances of the emergency, individuals to whom
    the product is administered are informed of the emergency use of the
    product, risks and benefits of the product, and of the option to accept
    or refuse the product. Further, the Commissioner is given the authority
    to impose other conditions on those who carry out activities for which
    the authorization is issued. Such conditions imposed by the
    Commissioner should be designed to provide maximum flexibility to
    ensure that those who wish to take the product can indeed take the
    product, if made available by the manufacturer.
        Section 564(e) also applies to unapproved uses of approved
    products and the Commissioner may, for manufacturers who choose
    to carry out one or more activities pursuant to an emergency
    use authorization, apply certain conditions. This subsection
    makes clear that manufacturers do not have to avail themselves
    of the emergency use authorization for unapproved uses of
    approved products, and it makes clear that no individual may
    alter or obscure the labeling of already approved products. It
    does authorize, however, persons other than the manufacturer to
    provide information about the product concerning the emergency
    use of the product.
        Under section 564(e), the Commissioner may establish
    conditions regarding product labeling and information
    conveyance concerning unapproved products. Further, the
    Committee intends that the Commissioner may establish
    conditions regarding product labeling and information
    conveyance on manufacturers that carry out one or more
    activities pursuant to an emergency use authorization with
    respect to the emergency use of that product that is an
    unapproved use of an approved product.
        Subsection (f) makes clear that an emergency use
    authorization is effective until the declaration is terminated
    or revoked, but allows patients to continue using such products
    in certain instances. Nothing in this subsection is intended to
    require manufacturers or others to provide such products to
    patients.
        Subsection (g) makes clear that the Commissioner shall
    periodically review the appropriations of an authorization, and
    it provides the Commissioner needed flexibility to revoke an
    authorization if the criteria justifying the authorization are
    no longer met.
        Subsection (h) ensures that the Commissioner shall promptly
    publish in the Federal Register notices of all authorizations,
    terminations, and revocations, Subsection (i) makes clear that
    all determinations under this new section are committed to
    agency discretion. Subsection (j) is a rule of construction
    nothing that this new section does not impair or otherwise
    affect certain existing authorities.
        New section 564(k) pertains to members of the Armed Forces
    and, among other things, it specifies that the President may
    waive requirements designed to ensure that such members are
    informed of the option to accept or refuse administration of an
    emergency use product, upon certain findings (which are
    identical to the findings found in section 1107 of Title 10).
    Further, the subsection requires that if certain information is
    not provided to members of the Armed Forces prior to an
    emergency use product being administered to them, then
    information concerning the administration of the product shall
    be placed in the medical record of the member.
        Subsection (l) makes clear that if a product is authorized
    for emergency use under this new section, the investigational
    sections of the Act shall not apply to the products.
        Subsection (m) ensures that no authority in new section 564
    can require a manufacturer of a drug, device, or biological
    product to perform any activity that becomes lawful pursuant to
    the new section. That is, the Commissioner in no way is goven
    the authority to, among other things, require a manufacturer to
    introduce into interstate commerce or deliver for introduction
    into interstate commerce any unapproved product or an approved
    product for an unapproved use under this section. Further, even
    if the Commissioner authorizes the emergency use of an already-
    approved, licensed or cleared product, a manufacturer can
    refuse to avail themselves of such emergency use authorization
    and continue introducing into interstate commerce its approved
    or cleared product under the Federal Food, Drug and Cosmetic
    Act, or licensed product pursuant to the Public Health Service
    Act. The only obligation in subsection (m) is that if the
    Commissioner authorizes the emergency use of a sole-source
    unapproved product, then the manufacturer of such product must
    inform the Commissioner of its intention not to carry out any
    activity under the authorization within a reasonable period of
    time. Nothing in this section shall be construed as authorizing
    the Commissioner to establish conditions on the distribution,
    administration, or labeling of any other product in any other
    circumstance.
        Subsection (n) ensures that the present enforcement regime
    of the Federal Food, Drug, and Cosmetic Act will apply to
    individuals who carry out an activity or activities pursuant to
    an authorization, but fail to comply with applicable
    conditions. If any person carries out an activity pursuant to
    section 564, but violates a condition imposed by the
    Commissioner, then that person will be subject to Chapter III
    of the Act, where the ``prohibited acts'' are found. If a
    person is found to be in violation of a prohibited act found in
    section 301, then the Committee intends for that person to be
    subject to the enforcement provisions found in sections 302,
    303, and 304. A violation of any condition applied to an
    emergency use product in no way alters or affects the emergency
    use status of the underlying product.
        The Committee intends that new section 564, as made clear
    in section 903(d)(2) of the Federal Food, Drug, and Cosmetic
    Act, the Secretary, through the Commissioner of Food and Drugs,
    shall be responsible for executing the Federal Food Drug, and
    Cosmetic Act as amended by the Project BioShield Act.

    Section 5. Reports

        Section 5(a) requires the Secretary of HHS to submit annual
    reports to Congress concerning the exercise of many of the new
    authorities under the Act. Section 5(b) requires a report from
    the National Academy of Sciences concerning whether and to what
    extent the research authorities granted under the Act have
    enhanced the development of biomedical countermeasures
    affecting national security. Section 5(c) requires the General
    Accounting Office to issue a report concerning the Secretary of
    HHS utilization of these new authorities.

                            Committee Correspondence

                                    Committee on the Judiciary,
                                         Washington, DC, June 10, 2003.
    Hon. Billy Tauzin,
    Chairman, Committee on Energy and Commerce,
    House of Representatives, Washington, DC.
        Dear Chairman Tauzin: In recognition of the desire to
    expedite floor consideration of H.R. 2122, the ``Project
    BioShield Act of 2003,'' the Committee on the Judiciary hereby
    waives consideration of the bill. Section 2 of the bill creates
    a new section 319F-1 of the Public Health Service Act. New
    subsection 319F-1(d) gives the Secretary of Health and Human
    Services new authority to enter into personal services
    contracts with scientists and consultants for limited periods
    of time for the purposes of expedited research on
    countermeasures against biological weapons. New subsection
    319F-1(d) further provides that scientists and consultants who
    receive contracts under this provision shall have the
    protections of the Federal Tort Claims Act as if they were
    regular federal employees. These FTCA provisions fall within
    the Committee on the Judiciary's Rule X jurisdiction. However,
    given the need to expedite this legislation, I will not seek a
    sequential referral based on their inclusion.
        The Committee on the Judiciary takes this action with the
    understanding that the Committee's jurisdiction over these
    provisions is in no way diminished or altered. I would
    appreciate your including this letter in the Congressional
    Record during consideration of H.R. 2122 on the House floor.
                Sincerely,
                                   F. James Sensenbrenner, Jr.,
                                                              Chairman.
                                    ------

                              Committee on Energy and Commerce,
                                         Washington, DC, June 10, 2003.
    Hon. F. James Sensenbrenner, Jr.,
    Chairman, Committee on the Judiciary,
    House of Representatives, Washington, DC.
        Dear Chairman Sensenbrenner: Thank you for your letter
    regarding H.R. 2122, the ``Project BioShield Act of 2003.'' As
    you noted, new subsection 319F-1(d) of the Public Health
    Service Act as added by the bill contains provisions that fall
    within the Rule X jurisdiction of the Committee on the
    Judiciary.
        I appreciate your willingness not to seek a referral on
    H.R. 2122. I agree that your decision to forego action on the
    bill will not prejudice the Committee on the Judiciary with
    respect to its jurisdictional prerogatives on this or similar
    legislation.
        I will include a copy of your letter and this response in
    the Congressional Record during consideration of H.R. 2122 of
    the House floor.
                Sincerely,
                                         W.J. ``Billy'' Tauzin,
                                                              Chairman.

             Changes in Existing Law Made by the Bill, as Reported

          In compliance with clause 3(e) of rule XIII of the Rules
    of the House of Representatives, changes in existing law made
    by the bill, as reported, are shown as follows (existing law
    proposed to be omitted is enclosed in black brackets, new
    matter is printed in italics, existing law in which no change
    is proposed is shown in roman):

    PUBLIC HEALTH SERVICE ACT

               *       *       *       *       *       *       *

    TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

               *       *       *       *       *       *       *

    Part B--Federal-State Cooperation

               *       *       *       *       *       *       *

    SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
                        BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
                        ACTIVITIES.

      (a) In General.--
              (1) Authority.--In conducting and supporting research
            and development activities regarding biomedical
            countermeasures under section 319F(h), the Secretary
            may conduct and support such activities in accordance
            with this section if the activities concern qualified
            countermeasures.
              (2) Qualified countermeasure.--For purposes of this
            section, the term ``qualified countermeasure'' means a
            priority countermeasure (as defined in section 319F(h))
            that affects national security.
              (3) Interagency cooperation.--
                      (A) In general.--In carrying out activities
                    under this section, the Secretary is
                    authorized, subject to subparagraph (B), to
                    enter into interagency agreements and other
                    collaborative undertakings with other agencies
                    of the United States Government.
                      (B) Limitation.--An agreement or undertaking
                    under this paragraph shall not authorize
                    another agency to exercise the authorities
                    provided by this section.
              (4) Availability of facilities to the secretary.--In
            any grant or cooperative agreement entered into under
            the authority provided in this section with respect to
            a biocontainment laboratory or other related or
            ancillary specialized research facility that the
            Secretary determines necessary for the purpose of
            performing, administering, and supporting qualified
            countermeasure research and development, the Secretary
            may provide that the facility that is the object of
            such grant or cooperative agreement shall be available
            as needed to the Secretary to respond to public health
            emergencies affecting national security.
      (b) Expedited Procurement Authority.--
              (1) Increased simplified acquisition threshold for
            biomedical countermeasure procurements.--
                      (A) In general.--For any procurement by the
                    Secretary of property or services for use (as
                    determined by the Secretary) in performing,
                    administering, or supporting qualified
                    countermeasure research or development
                    activities under this section that the
                    Secretary determines necessary to respond to
                    pressing research and development needs under
                    this section, the amount specified in section
                    4(11) of the Office of Federal Procurement
                    Policy Act (41 U.S.C. 403(11)), as applicable
                    pursuant to section 302A(a) of the Federal
                    Property and Administrative Services Act of
                    1949 (41 U.S.C. 252a(a)), shall be deemed to be
                    $25,000,000 in the administration, with respect
                    to such procurement, of--
                              (i) section 303(g)(1)(A) of the
                            Federal Property and Administrative
                            Services Act of 1949 (41 U.S.C.
                            253(g)(1)(A)) and its implementing
                            regulations; and
                              (ii) section 302A(b) of such Act (41
                            U.S.C. 252a(b)) and its implementing
                            regulations.
                      (B) Application of certain provisions.--
                    Notwithstanding subparagraph (A) and the
                    provision of law and regulations referred to in
                    such subparagraph, each of the following
                    provisions shall apply to procurements
                    described in this paragraph to the same extent
                    that such provisions would apply to such
                    procurements in the absence of subparagraph
                    (A):
                              (i) Chapter 37 of title 40, United
                            States Code (relating to contract work
                            hours and safety standards).
                              (ii) Subsections (a) and (b) of
                            Section 7 of the Anti-Kickback Act of
                            1986 (41 U.S.C. 57(a) and (b)).
                              (iii) Section 304C of the Federal
                            Property and Administrative Services
                            Act of 1949 (41 U.S.C. 254d) (relating
                            to the --- examination of contractor
                            records).
                      (C) Internal controls to be instituted.--The
                    Secretary shall institute appropriate internal
                    controls for procurements that are under this
                    paragraph, including requirements with regard
                    to documenting the justification for use of the
                    authority in this paragraph.
              (2) Use of noncompetitive procedures.--In addition to
            any other authority to use procedures other than
            competitive procedures, the Secretary may use such
            other procedures when--
                      (A) the procurement is as described by
                    paragraph (1); and
                      (B) the property or services needed by the
                    Secretary are available from only one
                    responsible source or only from a limited
                    number of responsible sources, and no other
                    type of property or services will satisfy the
                    Secretary's needs.
              (3) Increased micropurchase threshold.--
                      (A) In general.--For a procurement described
                    by paragraph (1), the amount specified in
                    subsections (c), (d), and (f) of section 32 of
                    the Office of Federal Procurement Policy Act
                    (41 U.S.C. 428) shall be deemed to be $15,000in
    the administration of that section with respect to such procurement.
                      (B) Internal controls to be instituted.--The
                    Secretary shall institute appropriate internal
                    controls for purchases that are under this
                    paragraph and that are greater than $2,500.
                      (C) Exception to preference for purchase card
                    mechanism.--No provision of law establishing a
                    preference for using a Government purchase card
                    method for purchases shall apply to purchases
                    that are under this paragraph and that are
                    greater than $2,500.
      (c) Authority To Expedite Peer Review.--
              (1) In general.--The Secretary may, as the Secretary
            determines necessary to respond to pressing qualified
            countermeasure research and development needs under
            this section, employ such expedited peer review
            procedures (including consultation with appropriate
            scientific experts) as the Secretary, in consultation
            with the Director of NIH, deems appropriate to obtain
            assessment of scientific and technical merit and likely
            contribution to the field of qualified countermeasure
            research, in place of the peer review and advisory
            council review procedures that would be required under
            sections 301(a)(3), 405(b)(1)(B), 405(b)(2),
            406(a)(3)(A), 492, and 494, as applicable to a grant,
            contract, or cooperative agreement--
                      (A) that is for performing, administering, or
                    supporting qualified countermeasure research
                    and development activities; and
                      (B) the amount of which is not greater than
                    $1,500,000.
              (2) Subsequent phases of research.--The Secretary's
            determination of whether to employ expedited peer
            review with respect to subsequent phases of a research
            grant or cooperative agreement under this section shall
            be determined without regard to the peer review
            procedures used for any prior peer review of that same
            grant or cooperative agreement.
      (d) Authority for Personal Services Contracts.--
              (1) In general.--For the purpose of performing,
            administering, and supporting qualified countermeasure
            research and development activities, the Secretary may,
            as the Secretary determines necessary to respond to
            pressing qualified countermeasure research and
            development needs under this section, obtain by
            contract (in accordance with section 3109 of title 5,
            United States Code, but without regard to the
            limitations in such section on the period of service
            and on pay) the personal services of experts or
            consultants who have scientific or other professional
            qualifications, except that in no case shall the
            compensation provided to any such expert or consultant
            exceed the daily equivalent of the annual rate of
            compensation for the President.
              (2) Federal tort claims act coverage.--
                      (A) In general.--A person carrying out a
                    contract under paragraph (1), and an officer,
                    employee, or governing board member of such
                    person, shall be deemed to be an employee of
                    the Department of Health and Human Services for
                    purposes of claims under sections 1346(b) and
                    2672 of title 28, United States Code, for money
                    damages for personal injury, including death,
                    resulting from performance of functions under
                    such contract.
                      (B) Exclusivity of remedy.--The remedy
                    provided by subparagraph (A) shall be exclusive
                    of any other civil action or proceeding by
                    reason of the same subject matter against the
                    person, officer, employee, or governing board
                    member.
              (3) Internal controls to be instituted.--
                      (A) In general.--The Secretary shall
                    institute appropriate internal controls for
                    contracts under this subsection, including
                    procedures for the Secretary to make a
                    determination of whether a person, or an
                    officer, employee, or governing board member of
                    a person, is deemed to be an employee of the
                    Department of Health and Human Services
                    pursuant to paragraph (2).
                      (B) Determination of employee status to be
                    final.--A determination by the Secretary under
                    subparagraph (A) that a person, or an officer,
                    employee, or governing board member of a
                    person, is or is not deemed to be an employee
                    of the Department of Health and Human Services
                    shall be final and binding on the Secretary and
                    the Attorney General and other parties to any
                    civil action or proceeding.
              (4) Number of personal services contracts limited.--
            The number of experts and consultants whose personal
            services are obtained under paragraph (1) shall not
            exceed 30 at any time.
      (e) Streamlined Personnel Authority.--
              (1) In general.--In addition to any other personnel
            authorities, the Secretary may, as the Secretary
            determines necessary to respond to pressing qualified
            countermeasure research and development needs under
            this section, without regard to such provisions of
            title 5, United States Code, governing appointments in
            the competitive service, and without regard to the
            provisions of chapter 51 and subchapter III of chapter
            53 of such title relating to classification and General
            Schedule pay rates, appoint professional and technical
            employees, not to exceed 30 such employees at any time,
            to positions in the National Institutes of Health to
            perform, administer, or support qualified
            countermeasure research and development activities in
            carrying out this section.
              (2) Internal controls to be instituted.--The
            Secretary shall institute appropriate internal controls
            for appointments under this subsection.
      (f) Actions Committed to Agency Discretion.--Actions by the
    Secretary under the authority of this section are committed to
    agency discretion.

    SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

      (a) Strategic National Stockpile.--
              (1) In general.--The Secretary of Homeland Security
            (referred to in this section as the ``Homeland Security
            Secretary''), in coordination with the Secretary and
            the Secretary of Veterans Affairs, shall maintain a
            stockpile or stockpiles of drugs, vaccines and other
            biological products, medical devices, and other
            supplies in such numbers, types, and amounts as are
            determined by the Secretary to be appropriate and
            practicable, taking into account other available
            sources, to provide for the emergency health security
            of the United States, including the emergency health
            security of children and other vulnerable populations,
            in the event of a bioterrorist attack or other public
            health emergency.
              (2) Procedures.--The Secretary, in managing the
            stockpile under paragraph (1), shall--
                      (A) consult with the working group under
                    section 319F(a);
                      (B) ensure that adequate procedures are
                    followed with respect to such stockpile for
                    inventory management and accounting, and for
                    the physical security of the stockpile;
                      (C) in consultation with Federal, State, and
                    local officials, take into consideration the
                    timing and location of special events;
                      (D) review and revise, as appropriate, the
                    contents of the stockpile on a regular basis to
                    ensure that emerging threats, advanced
                    technologies, and new countermeasures are
                    adequately considered;
                      (E) devise plans for the effective and timely
                    supply-chain management of the stockpile, in
                    consultation with appropriate Federal, State
                    and local agencies, and the public and private
                    health care infrastructure; and
                      (F) ensure the adequate physical security of
                    the stockpile.
      (b) Smallpox Vaccine Development.--
              (1) In general.--The Secretary shall award contracts,
            enter into cooperative agreements, or carry out such
            other activities as may reasonably be required in order
            to ensure that the stockpile under subsection (a)
            includes an amount of vaccine against smallpox as
            determined by such Secretary to be sufficient to meet
            the health security needs of the United States.
              (2) Rule of construction.--Nothing in this section
            shall be construed to limit the private distribution,
            purchase, or sale of vaccines from sources other than
            the stockpile described in subsection (a).
      (c) Additional Authority Regarding Procurement of Certain
    Biomedical Countermeasures; Availability of Special Reserve
    Fund.--
              (1) In general.--
                      (A) Use of fund.--A security countermeasure
                    may, in accordance with this subsection, be
                    procured with amounts in the special reserve
                    fund under paragraph (10).
                      (B) Security countermeasure.--For purposes of
                    this subsection, the term ``security
                    countermeasure'' means a priority
                    countermeasure (as defined in section
                    319F(h))--
                              (i) that affects national security;
                              (ii) that is determined under
                            paragraph (2)(B)(ii) to be a necessary
                            countermeasure; and
                              (iii)(I) that is approved or cleared
                            under chapter V of the Federal Food,
                            Drug, and Cosmetic Act, or licensed
                            under section 351 of this Act, for use
                            as a countermeasure to a chemical,
                            biological, radiological, or nuclear
                            agent identified as a material threat
                            under paragraph (2)(A)(ii); or
                              (II) for which the Secretary
                            determines that sufficient and
                            satisfactory clinical experience or
                            research data (including data, if
                            available, from pre-clinical and
                            clinical trials) support a reasonable
                            conclusion that the countermeasure will
                            qualify for approval or licensing after
                            the date of a determination under
                            paragraph (5).
              (2) Determination of material threats.--
                      (A) material threat.--The Homeland Security
                    Secretary, in consultation with the heads of
                    other agencies as appropriate, shall on an
                    ongoing basis--
                              (i) assess current and emerging
                            threats of chemical, biological,
                            radiological, and nuclear agents; and
                              (ii) determine which of such agents
                            present a material threat against the
                            United States population.
                      (B) Public health impact; necessary
                    countermeasures.--The Secretary shall on an
                    ongoing basis--
                              (i) assess the potential public
                            health consequences of use against the
                            United States population of agents
                            identified under subparagraph (A)(ii);
                            and
                              (ii) determine, on the basis of such
                            assessment, the agents for which
                            priority countermeasures are necessary
                            to protect the public health from a
                            material threat.
              (3) Assessment of availability and appropriateness of
            countermeasures.--The Secretary, in consultation with
            the Homeland Security Secretary, shall assess on an
            ongoing basis the availability and appropriateness of
            specific countermeasures to address specific threats
            identified under paragraph (2).
              (4) Call for security countermeasures; commitment for
            recommendation for procurement.--
                      (A) Proposal to the president.--If, pursuant
                    to an assessment under paragraph (3), the
                    Homeland Security Secretary and the Secretary
                    make a determination that a security
                    countermeasure would be appropriate, such
                    Secretaries may jointly submit to the President
                    a proposal to--
                              (i) issue a call for the development
                            of such security countermeasure; and
                              (ii) make a commitment that, upon the
                            first development of such security
                            countermeasure that meets the
                            conditions for procurement under
                            paragraph (5), the Secretaries will,
                            based in part on information obtained
                            pursuant to such call, make a
                            recommendation under paragraph (6) that
                            the special reserve fund under
                            paragraph (10) be made available for
                            the procurement of such security
                            countermeasure.
                      (B) Countermeasure specifications.--The
                    Homeland Security Secretary and the Secretary
                    shall, to the extent practicable, include in
                    the proposal under subparagraph (A)--
                              (i) estimated quantity of purchase
                            (in the form of number of doses or
                            number of effective courses of
                            treatments regardless of dosage form);
                              (ii) necessary measures of minimum
                            safety and effectiveness;
                              (iii) estimated price for each dose
                            or effective course of treatment
                            regardless of dosage form; and
                              (iv) other information that may be
                            necessary to encourage and facilitate
                            research, development, and manufacture
                            of the countermeasure or to provide
                            specifications for the countermeasure.
                      (C) Presidential approval.--If the President
                    approves a proposal under subparagraph (A), the
                    Homeland Security Secretary and the Secretary
                    shall make known to persons who may respond to
                    a call for the security countermeasure
                    involved--
                              (i) the call for the countermeasure;
                              (ii) specifications for the
                            countermeasure under subparagraph (B);
                            and
                              (iii) a commitment described in
                            subparagraph (A)(ii).
              (5) Secretary's determination of countermeasures
            appropriate for funding from special reserve fund.--
                      (A) In general.--The Secretary, in accordance
                    with the provisions of this paragraph, shall
                    identify specific security countermeasures that
                    the Secretary determines, in consultation with
                    the Homeland Security Secretary, to be
                    appropriate for inclusion in the stockpile
                    under subsection (a) pursuant to procurements
                    made with amounts in the special reserve fund
                    under paragraph (10) (referred to in this
                    subsection individually as a ``procurement
                    under this subsection'').
                      (B) Requirements.--In making a determination
                    under subparagraph (A) with respect to a
                    security countermeasure, the Secretary shall
                    determine and consider the following:
                              (i) The quantities of the product
                            that will be needed to meet the needs
                            of the stockpile.
                              (ii) The feasibility of production
                            and delivery within five years of
                            sufficient quantities of the product.
                              (iii) Whether there is a lack of a
                            significant commercial market for the
                            product at the time of procurement,
                            other than as a security
                            countermeasure.
              (6) Recommendation for president's approval.--
                      (A) Recommendation for procurement.--In the
                    case of a security countermeasure that the
                    Secretary has, in accordance with paragraphs
                    (2), (3), and (5), determined to be appropriate
                    for procurement under this subsection, the
                    Homeland Security Secretary and the Secretary
                    shall jointly submit to the President, in
                    coordination with the Director of the Office of
                    Management and Budget, a recommendation that
                    the special reserve fund under paragraph(10) be
    made available for the procurement of such countermeasure.
                      (B) Presidential approval.--The special
                    reserve fund under paragraph (10) is available
                    for a procurement of a security countermeasure
                    only if the President has approved a
                    recommendation under subparagraph (A) regarding
                    the countermeasure.
                      (C) Notice to congress.--The Secretary and
                    the Homeland Security Secretary shall notify
                    the Congress of each decision of the President
                    to approve a recommendation under subparagraph
                    (A). Such notice shall include an explanation
                    of the decision to make available the special
                    reserve fund under paragraph (10) for
                    procurement of such a countermeasure,
                    including, where available, the identification
                    of the potential supplier or suppliers of such
                    countermeasure, and whether other potential
                    suppliers of the same or similar
                    countermeasures were considered and rejected
                    for procurement under this section and the
                    reasons therefor.
                      (D) Subsequent specific countermeasures.--
                    Procurement under this subsection of a security
                    countermeasure for a particular purpose does
                    not preclude the subsequent procurement under
                    this subsection of any other security
                    countermeasure for such purpose if the
                    Secretary has determined under paragraph (5)(A)
                    that such countermeasure is appropriate for
                    inclusion in the stockpile and if, as
                    determined by the Secretary, such
                    countermeasure provides improved safety or
                    effectiveness, or for other reasons enhances
                    preparedness to respond to threats of use of a
                    biological, chemical, radiological, or nuclear
                    agent. Such a determination by the Secretary is
                    committed to agency discretion.
                      (E) Rule of construction.--Recommendations
                    and approvals under this paragraph apply solely
                    to determinations that the special reserve fund
                    under paragraph (10) will be made available for
                    a procurement of a security countermeasure, and
                    not to the substance of contracts for such
                    procurement or other matters relating to awards
                    of such contracts.
              (7) Procurement.--
                      (A) In general.--For purposes of a
                    procurement under this subsection that is
                    approved by the President under paragraph (6),
                    the Homeland Security Secretary and the
                    Secretary shall have responsibilities in
                    accordance with subparagraphs (B) and (C).
                      (B) Interagency agreements.--
                              (i) For procurement.--The Homeland
                            Security Secretary shall enter into an
                            agreement with the Secretary for
                            procurement of a security
                            countermeasure in accordance with the
                            provisions of this paragraph. The
                            special reserve fund under paragraph
                            (10) shall be available for the
                            Secretary's costs of such procurement,
                            other than as provided in clause (ii).
                              (ii) For administrative costs.--The
                            agreement entered into between the
                            Homeland Security Secretary and the
                            Secretary for managing the stockpile
                            under subsection (a) shall provide for
                            reimbursement of the Secretary's
                            administrative costs relating to
                            procurements under this subsection.
                      (C) Procurement.--
                              (i) In general.--The Secretary shall
                            be responsible for--
                                      (I) arranging for procurement
                                    of a security countermeasure,
                                    including negotiating terms
                                    (including quantity, production
                                    schedule, and price) of, and
                                    entering into, contracts and
                                    cooperative agreements, and for
                                    carrying out such other
                                    activities as may reasonably be
                                    required, in accordance with
                                    the provisions of this
                                    subparagraph; and
                                      (II) promulgating regulations
                                    to implement clauses (v), (vi),
                                    and (vii), and any other
                                    provisions of this subsection.
                              (ii) Contract terms.--A contract for
                            procurements under this subsection
                            shall (or, as specified below, may)
                            include the following terms:
                                      (I) Payment conditioned on
                                    substantial delivery.--The
                                    contract shall provide that no
                                    payment may be made until
                                    delivery has been made of a
                                    substantial portion (as
                                    determined by the Secretary) of
                                    the total number of units
                                    contracted for, except that,
                                    notwithstanding any other
                                    provision of law, the contract
                                    may provide that, if the
                                    Secretary determines (in the
                                    Secretary's discretion) that an
                                    advance payment is necessary to
                                    ensure success of a project,
                                    the Secretary may pay an
                                    amount, not to exceed 10
                                    percent of the contract amount,
                                    in advance of delivery. The
                                    contract shall provide that
                                    such advance payment is
                                    required to be repaid if there
                                    is a failure to perform under
                                    the contract, except in special
                                    circumstances as determined by
                                    the Secretary on a contract by
                                    contract basis.
                                      (II) Contract duration.--The
                                    contract shall be for a period
                                    not to exceed five years,
                                    except that, in first awarding
                                    the contract, the Secretary may
                                    provide for a longer duration,
                                    not exceeding eight years, if
                                    the Secretary determines that
                                    complexities or other
                                    difficulties in performance
                                    under the contract justify such
                                    a period. The contract shall be
                                    renewable for additional
                                    periods, none of which shall
                                    exceed five years.
                                      (III) Storage by vendor.--The
                                    contract may provide that the
                                    vendor will provide storage for
                                    stocks of a product delivered
                                    to the ownership of the Federal
                                    Government under the contract,
                                    for such period and under such
                                    terms and conditions as the
                                    Secretary may specify, and in
                                    such case amounts from the
                                    special reserve fund under
                                    paragraph (10) shall be
                                    available for costs of
                                    shipping,handling, storage, and
    related costs for such product.
                              (iii) Availability of simplified
                            acquisition procedures.--
                                      (I) In general.--The amount
                                    of any procurement under this
                                    subsection shall be deemed to
                                    be below the threshold amount
                                    specified in section 4(11) of
                                    the Office of Federal
                                    Procurement Policy Act (41
                                    U.S.C. 403(11)), for purposes
                                    of application to such
                                    procurement, pursuant to
                                    section 302A(a) of the Federal
                                    Property and Administrative
                                    Services Act of 1949 (41 U.S.C.
                                    252a(a)), of--
                                              (aa) section
                                            303(g)(1)(A) of the
                                            Federal Property and
                                            Administrative Services
                                            Act of 1949 (41 U.S.C.
                                            253(g)(1)(A)) and its
                                            implementing
                                            regulations; and
                                              (bb) section 302A(b)
                                            of such Act (41 U.S.C.
                                            252a(b)) and its
                                            implementing
                                            regulations.
                                      (II) Application of certain
                                    provisions.--Notwithstanding
                                    subclause (I) and the provision
                                    of law and regulations referred
                                    to in such clause, each of the
                                    following provisions shall
                                    apply to procurements described
                                    in this clause to the same
                                    extent that such provisions
                                    would apply to such
                                    procurements in the absence of
                                    subclause (I):
                                              (aa) Chapter 37 of
                                            title 40, United States
                                            Code (relating to
                                            contract work hours and
                                            safety standards).
                                              (bb) Subsections (a)
                                            and (b) of Section 7 of
                                            the Anti-Kickback Act
                                            of 1986 (41 U.S.C.
                                            57(a) and (b)).
                                              (cc) Section 304C of
                                            the Federal Property
                                            and Administrative
                                            Services Act of 1949
                                            (41 U.S.C. 254d)
                                            (relating to the ---
                                            examination of
                                            contractor records).
                              (iv) Use of noncompetitive
                            procedures.--In addition to any other
                            authority to use procedures other than
                            competitive procedures, the Secretary
                            may use such other procedures for a
                            procurement under this subsection if
                            the product is available from only one
                            responsible source or only from a
                            limited number of responsible sources,
                            and no other type of product will
                            satisfy the Secretary's needs.
                              (v) Premium provision in multiple
                            award contracts.--
                                      (I) In general.--If, under
                                    this subsection, the Secretary
                                    enters into contracts with more
                                    than one vendor to procure a
                                    security countermeasure, such
                                    Secretary may, notwithstanding
                                    any other provision of law,
                                    include in each of such
                                    contracts a provision that--
                                              (aa) identifies an
                                            increment of the total
                                            quantity of security
                                            countermeasure
                                            required, whether by
                                            percentage or by
                                            numbers of units; and
                                              (bb) promises to pay
                                            one or more specified
                                            premiums based on the
                                            priority of such
                                            vendors' production and
                                            delivery of the
                                            increment identified
                                            under item (aa), in
                                            accordance with the
                                            terms and conditions of
                                            the contract.
                                      (II) Determination of
                                    government's requirement not
                                    reviewable.--If the Secretary
                                    includes in each of a set of
                                    contracts a provision as
                                    described in subclause (I),
                                    such Secretary's determination
                                    of the total quantity of
                                    security countermeasure
                                    required, and any amendment of
                                    such determination, is
                                    committed to agency discretion.
                              (vi) Extension of closing date for
                            receipt of proposals not reviewable.--A
                            decision by the Secretary to extend the
                            closing date for receipt of proposals
                            for a procurement under this subsection
                            is committed to agency discretion.
                              (vii) Limiting competition to sources
                            responding to request for
                            information.--In conducting a
                            procurement under this subsection, the
                            Secretary may exclude a source that has
                            not responded to a request for
                            information under section 303A(a)(1)(B)
                            of the Federal Property and
                            Administrative Services Act of 1949 (41
                            U.S.C. 253a(a)(1)(B)) if such request
                            has given notice that the Secretary may
                            so exclude such a source.
              (8) Interagency cooperation.--
                      (A) In general.--In carrying out activities
                    under this section, the Homeland Security
                    Secretary and the Secretary are authorized,
                    subject to subparagraph (B), to enter into
                    interagency agreements and other collaborative
                    undertakings with other agencies of the United
                    States Government.
                      (B) Limitation.--An agreement or undertaking
                    under this paragraph shall not authorize
                    another agency to exercise the authorities
                    provided by this section to the Homeland
                    Security Secretary or to the Secretary.
              (9) Restrictions on use of funds.--Amounts in the
            special reserve fund under paragraph (10) shall not be
            used to pay--
                      (A) costs for the purchase of vaccines under
                    procurement contracts entered into before the
                    date of the enactment of the Project BioShield
                    Act of 2003; or
                      (B) administrative costs.
              (10) Special reserve fund.--For purposes of this
            subsection, the term ``special reserve fund'' has the
            meaning given such term in section 510 of the Homeland
            Security Act of 2002.
      (d) Disclosures.--No Federal agency shall disclose under
    section 552, United States Code, any information identifying
    the location at which materials in the stockpile under
    subsection (a) are stored.
      (e) Definition.--For purposes of subsection (a), the term
    ``stockpile'' includes--
              (1) a physical accumulation (at one or more
            locations) of the supplies described in subsection (a);
            or
              (2) a contractual agreement between the Homeland
            Security Secretary and a vendor or vendors under which
            such vendor or vendors agree to provide to such
            Secretary supplies described in subsection (a).
      (f) Authorization of Appropriations.--
              (1) Strategic national stockpile.--For the purpose of
            carrying out subsection (a), there are authorized to be
            appropriated $640,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006. Such authorization is in addition to
            amounts in the special reserve fund under subsection
            (c)(10).
              (2) Smallpox vaccine development.--For the purpose of
            carrying out subsection (b), there are authorized to be
            appropriated $509,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006.

               *       *       *       *       *       *       *

    TITLE IV--NATIONAL RESEARCH INSTITUTES

               *       *       *       *       *       *       *

    Part E--Other Agencies of NIH

               *       *       *       *       *       *       *

    SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

      (a) Modernization and Construction of Facilities.--
              (1) In general.--The Director of NIH, acting through
            the Director of the Center or the Director of the
            National Institute of Allergy and Infectious Diseases,
            may make grants or contracts to public and nonprofit
            private entities to expand, remodel, renovate, or alter
            existing research facilities or construct new research
            facilities, subject to the provisions of this section.

               *       *       *       *       *       *       *

      (c) Requirements for Grants.--
              (1) In general.--The Director of the Center or the
            Director of the National Institute of Allergy and
            Infectious Diseases may make a grant under subsection
            (a) only if the applicant for the grant meets the
            following conditions:
                      (A) * * *

               *       *       *       *       *       *       *

              (2) Institutions of emerging excellence.--From the
            amount appropriated under [subsection (i)] subsection
            (i)(1) for a fiscal year up to $50,000,000, the
            Director of the Center shall make available 25 percent
            of such amount, and from the amount appropriated under
            such subsection for a fiscal year that is over
            $50,000,000, the Director of the Center shall make
            available up to 25 percent of such amount, for grants
            under subsection (a) to applicants that in addition to
            meeting the requirements established in paragraph (1),
            have demonstrated emerging excellence in biomedical or
            behavioral research, as follows:
                      (A) * * *

               *       *       *       *       *       *       *

      (d) Requirement of Application.--The Director of the Center
    or the Director of the National Institute of Allergy and
    Infectious Diseases may make a grant under subsection (a) only
    if an application for the grant is submitted to the Director
    and the application is in such form, is made in such manner,
    and contains such agreements, assurances, and information as
    the Director determines to be necessary to carry out this
    section.
      (e) Amount of Grant; Payments.--
              (1) Amount.--The amount of any grant awarded under
            subsection (a) shall be determined by the Director of
            the Center or the Director of the National Institute of
            Allergy and Infectious Diseases, except that such
            amount shall not exceed--
                      (A) 50 percent (or, in the case of the
                    Institute, 75 percent) of the necessary cost of
                    the construction of a proposed facility as
                    determined by the Director; or
                      (B) in the case of a multipurpose facility,
                    40 percent (or, in the case of the Institute,
                    75 percent) of that part of the necessary cost
                    of construction that the Director determines to
                    be proportionate to the contemplated use of the
                    facility.
              (2) Reservation of amounts.--On the approval of any
            application for a grant under subsection (a), the
            Director of the Center or the Director of the National
            Institute of Allergy and Infectious Diseases shall
            reserve, from any appropriation available for such
            grants, the amount of such grant, and shall pay such
            amount, in advance or by way of reimbursement, and in
            such installments consistent with the construction
            progress, as the Director may determine appropriate.
            The reservation of any amount by the Director under
            this paragraph may be amended by the Director, either
            on the approval of an amendment of the application or
            on the revision of the estimated cost of construction
            of the facility.

               *       *       *       *       *       *       *

              (4) Waiver of limitations.--The limitations imposed
            under paragraph (1) may be waived at the discretion of
            the Director of the Center or the Director of the
            National Institute of Allergy and Infectious Diseases
            for applicants meeting the conditions described in
            subsection (c).
      (f ) Recapture of Payments.--If, not later than 20 years
    after the completion of construction for which a grant has been
    awarded under subsection (a)--
              (1) in the case of an award by the Director of the
            Center, the applicant or other owner of the facility
            shall cease to be a public or non profit private
            entity; or
              (2) the facility shall cease to be used for the
            research purposes for which it was constructed (unless
            the Director of the Center or the Director of the
            National Institute of Allergy and Infectious Diseases
            determines, in accordance with regulations,that there
    is good cause for releasing the applicant or other owner from
    obligation to do so),
    the United States shall be entitled to recover from the
    applicant or other owner of the facility the amount bearing the
    same ratio to the current value (as determined by an agreement
    between the parties or by action brought in the United States
    District Court for the district in which such facility is
    situated) of the facility as the amount of the Federal
    participation bore to the cost of the construction of such
    facility.

               *       *       *       *       *       *       *

      (i) Authorization of [Appropriations.--For the purpose of
    carrying out this section,] Appropriations.--
              (1) Center.--For the purpose of carrying out this
            section with respect to the Center, there are
            authorized to be appropriated $250,000,000 for fiscal
            year 2001, and such sums as may be necessary for each
            of the fiscal years 2002 and 2003.
              (2) National institute of allergy and infectious
            diseases.--For the purpose of carrying out this section
            with respect to the National Institute of Allergy and
            Infectious Diseases, there are authorized to be
            appropriated such sums as may be necessary for fiscal
            year 2003.
                                  ----------

                SECTION 510 OF THE HOMELAND SECURITY ACT OF 2002

    SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR STRATEGIC
                        NATIONAL STOCKPILE.

      (a) Authorization of Appropriations.--For procurement of
    security countermeasures under section 319F-2(c) of the Public
    Health Service Act (referred to in this section as the
    ``security countermeasures program''), there is authorized to
    be appropriated up to $5,593,000,000 for the fiscal years 2004
    through 2013. Of the amounts appropriated under the preceding
    sentence, not to exceed $3,418,000,000 may be obligated during
    the fiscal years 2004 through 2008, of which not to exceed
    $890,000,000 may be obligated during fiscal year 2004.
      (b) Special Reserve Fund.--For purposes of the security
    countermeasures program, the term ``special reserve fund''
    means the appropriations account established as a result of any
    appropriations made under subsection (a).
      (c) Availability.--
              (1) Duration of availability for obligation.--Subject
            to paragraph (2), all amounts appropriated under
            subsection (a) are available for obligation through the
            end of fiscal year 2013, provided that any portion of
            such amount that remains unobligated for such purposes
            on the expiration of such term shall be returned to the
            United States Treasury and shall not be available for
            subsequent obligation for any purpose.
              (2) Initial availability for particular
            procurements.--Amounts appropriated under subsection
            (a) become available for a procurement under the
            security countermeasures program only upon the approval
            by the President of such availability for the
            procurement in accordance with paragraph (6)(B) of such
            program.
                                  ----------

    SECTION 121 OF THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS
                            AND RESPONSE ACT OF 2002

    [SEC. 121. STRATEGIC NATIONAL STOCKPILE.

      [(a) Strategic National Stockpile.--
              [(1) In general.--The Secretary of Health and Human
            Services (referred to in this section as the
            ``Secretary''), in coordination with the Secretary of
            Veterans Affairs, shall maintain a stockpile or
            stockpiles of drugs, vaccines and other biological
            products, medical devices, and other supplies in such
            numbers, types, and amounts as are determined by the
            Secretary to be appropriate and practicable, taking
            into account other available sources, to provide for
            the emergency health security of the United States,
            including the emergency health security of children and
            other vulnerable populations, in the event of a
            bioterrorist attack or other public health emergency.
              [(2) Procedures.--The Secretary, in managing the
            stockpile under paragraph (1), shall--
                      [(A) consult with the working group under
                    section 319F(a) of the Public Health Service
                    Act;
                      [(B) ensure that adequate procedures are
                    followed with respect to such stockpile for
                    inventory management and accounting, and for
                    the physical security of the stockpile;
                      [(C) in consultation with Federal, State, and
                    local officials, take into consideration the
                    timing and location of special events;
                      [(D) review and revise, as appropriate, the
                    contents of the stockpile on a regular basis to
                    ensure that emerging threats, advanced
                    technologies, and new countermeasures are
                    adequately considered;
                      [(E) devise plans for the effective and
                    timely supply-chain management of the
                    stockpile, in consultation with appropriate
                    Federal, State and local agencies, and the
                    public and private health care infrastructure;
                    and
                      [(F) ensure the adequate physical security of
                    the stockpile.
      [(b) Smallpox Vaccine Development.--
              [(1) In general.--The Secretary shall award
            contracts, enter into cooperative agreements, or carry
            out such other activities as may reasonably be required
            in order to ensure that the stockpile under subsection
            (a) includes an amount of vaccine against smallpox as
            determined by the Secretary to be sufficient to meet
            the health security needs of the United States.
              [(2) Rule of construction.--Nothing in this section
            shall be construed to limit the private distribution,
            purchase, or sale of vaccines from sources other than
            the stockpile described in subsection (a).
      [(c) Disclosures.--No Federal agency shall disclose under
    section 552, United States Code, any information identifying
    the location at which materials in the stockpile under
    subsection (a) are stored.
      [(d) Definition.--For purposes of subsection (a), the term
    ``stockpile'' includes--
              [(1) a physical accumulation (at one or more
            locations) of the supplies described in subsection (a);
            or
              [(2) a contractual agreement between the Secretary
            and a vendor or vendors under which such vendor or
            vendors agree to provide to the Secretary supplies
            described in subsection (a).
      [(e) Authorization of Appropriations.--
              [(1) Strategic national stockpile.--For the purpose
            of carrying out subsection (a), there are authorized to
            be appropriated $640,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006.
              [(2) Smallpox vaccine development.--For the purpose
            of carrying out subsection (b), there are authorized to
            be appropriated $509,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006.]
                                  ----------

            SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

    SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

      (a) In General.--
              (1) Emergency uses.--Notwithstanding sections 505,
            510(k), and 515 of this Act and section 351 of the
            Public Health Service Act, and subject to the
            provisions of this section, the Secretary may authorize
            the introduction into interstate commerce, during the
            effective period of a declaration under subsection (b),
            of a drug or device intended for use in an actual or
            potential emergency (referred to in this section as an
            ``emergency use'').
              (2) Approval status of product.--An authorization
            under paragraph (1) may authorize an emergency use of a
            product that--
                      (A) is not approved, licensed, or cleared for
                    commercial distribution under a provision of
                    law referred to in such paragraph (referred to
                    in this section as an ``unapproved product'');
                    or
                      (B) is approved, licensed, or cleared under
                    such a provision, but which use is not under
                    such provision an approved, licensed, or
                    cleared use of the product (referred to in this
                    section as an ``unapproved use of an approved
                    product'').
              (3) Relation to other uses.--An emergency use
            authorized under paragraph (1) for a product is in
            addition to any other use that is authorized for the
            product under a provision of law referred to in such
            paragraph.
              (4) Definitions.--For purposes of this section:
                      (A) The term ``emergency use'' has the
                    meaning indicated for such term in paragraph
                    (1).
                      (B) The term ``product'' means a drug or
                    device.
                      (C) The term ``unapproved product'' has the
                    meaning indicated for such term in paragraph
                    (2)(A).
                      (D) The term ``unapproved use of an approved
                    product'' has the meaning indicated for such
                    term in paragraph (2)(B).
      (b) Declaration of Emergency.--
              (1) In general.--The Secretary may declare an
            emergency justifying the authorization under this
            subsection for a product on the basis of--
                      (A) a determination by the Secretary of
                    Homeland Security that there is a national
                    emergency, or a significant potential for a
                    national emergency, involving a heightened risk
                    of attack with a specified biological,
                    chemical, radiological, or nuclear agent or
                    agents;
                      (B) a determination by the Secretary of
                    Defense that there is a military emergency, or
                    a significant potential for a military
                    emergency, involving a heightened risk to
                    United States military forces of attack with a
                    biological, chemical, radiological, or nuclear
                    agent or agents; or
                      (C) a determination by the Secretary of a
                    public health emergency under section 319 of
                    the Public Health Service Act, affecting
                    national security and involving a specified
                    biological, chemical, radiological, or nuclear
                    agent or agents, or a specified disease or
                    condition that may be attributable to such
                    agent or agents.
              (2) Termination of declaration.--
                      (A) In general.--A declaration under this
                    subsection shall terminate upon the earlier
                    of--
                              (i) a determination by the Secretary,
                            in consultation as appropriate with the
                            Secretary of Homeland Security or the
                            Secretary of Defense, that the
                            circumstances described in paragraph
                            (1) have ceased to exist; or
                              (ii) the expiration of the one-year
                            period beginning on the date on which
                            the declaration is made.
                      (B) Renewal.--Notwithstanding subparagraph
                    (A), the Secretary may renew a declaration
                    under this subsection, and this paragraph shall
                    apply to any such renewal.
              (3) Advance notice of termination.--In terminating a
            declaration under this section, the Secretary shall
            provide advance notice that the declaration will be
            terminated. The period of advance notice shall be a
            period reasonably determined to provide--
                      (A) in the case of an unapproved product, a
                    sufficient period for disposition of shipments
                    of the product, including the return of such
                    shipments to the manufacturer (in the case of a
                    manufacturer that chooses to have the shipments
                    returned); and
                      (B) in the case of unapproved uses of
                    approved products, a sufficient period for the
                    disposition of any labelingthat was provided
    with respect to the emergency use involved.
              (4) Publication.--The Secretary shall promptly
            publish in the Federal Register each declaration,
            determination, and renewal under this subsection.
      (c) Criteria for Issuance of Authorization.--The Secretary
    may issue an authorization under this section with respect to
    the emergency use of a product only if, after consultation with
    the Director of the National Institutes of Health and the
    Director of the Centers for Disease Control and Prevention, to
    the extent feasible and appropriate given the circumstances of
    the emergency involved, the Secretary concludes--
              (1) that an agent specified in a declaration under
            subsection (b) can cause a serious or life-threatening
            disease or condition;
              (2) that, based on the totality of scientific
            evidence available to the Secretary, including data
            from adequate and well-controlled clinical trials, if
            available, it is reasonable to believe that--
                      (A) the product may be effective in
                    detecting, diagnosing, treating, or
                    preventing--
                              (i) such disease or condition; or
                              (ii) a serious or life-threatening
                            disease or condition caused by a
                            product authorized under this section
                            or approved under this Act or the
                            Public Health Service Act, for
                            detecting, diagnosing, treating, or
                            preventing such a disease or condition
                            caused by such an agent; and
                      (B) the known and potential benefits of the
                    product, when used to detect, diagnose,
                    prevent, or treat such disease or condition,
                    outweigh the known and potential risks of the
                    product;
              (3) that there is no adequate, approved, and
            available alternative to the product for detecting,
            diagnosing, preventing, or treating such disease or
            condition; and
              (4) that such other criteria as the Secretary may by
            regulation prescribe are satisfied.
      (d) Scope of Authorization.--
              (1) In general.--An authorization of a product under
            this section shall state--
                      (A) each disease or condition that the
                    product may be used to detect, diagnose,
                    prevent, or treat within the scope of the
                    authorization;
                      (B) the Secretary's conclusions, made under
                    subsection (c)(2)(B), that the known and
                    potential benefits of the product, when used to
                    detect, diagnose, prevent, or treat such
                    disease or condition, outweigh the known and
                    potential risks of the product; and
                      (C) the Secretary's conclusions, made under
                    subsection (c), concerning the safety and
                    potential effectiveness of the product in
                    detecting, diagnosing, preventing, or treating
                    such diseases or conditions, including an
                    assessment of the available scientific
                    evidence.
              (2) Confidential information.--Nothing in this
            section alters or amends section 1905 of title 18,
            United States Code, or section 552(b)(4) of title 5 of
            such Code.
      (e) Conditions of Authorization.--
              (1) Unapproved product.--
                      (A) Required conditions.--With respect to the
                    emergency use of an unapproved product, the
                    Secretary, to the extent feasible given the
                    circumstances of the emergency, shall, for
                    persons who choose to carry out one or more
                    activities for which the authorization is
                    issued, establish such conditions on an
                    authorization under this section as the
                    Secretary finds necessary or appropriate to
                    protect the public health, including the
                    following:
                              (i) Appropriate conditions designed
                            to ensure that, to the extent feasible
                            given the circumstances of the
                            emergency, health care professionals
                            administering the product are
                            informed--
                                      (I) that the Secretary has
                                    authorized the emergency use of
                                    the product;
                                      (II) of the significant known
                                    and potential benefits and
                                    risks of the emergency use of
                                    the product, and of the extent
                                    to which such benefits and
                                    risks are unknown; and
                                      (III) of the alternatives to
                                    the product that are available,
                                    and of their benefits and
                                    risks.
                              (ii) Appropriate conditions designed
                            to ensure that, to the extent feasible
                            given the circumstances of the
                            emergency, individuals to whom the
                            product is administered are informed--
                                      (I) that the Secretary has
                                    authorized the emergency use of
                                    the product;
                                      (II) of the significant known
                                    and potential benefits and
                                    risks of such use, and of the
                                    extent to which such benefits
                                    and risks are unknown; and
                                      (III) of the option to accept
                                    or refuse administration of the
                                    product, of the consequences,
                                    if any, of refusing
                                    administration of the product,
                                    and of the alternatives to the
                                    product that are available and
                                    of their benefits and risks.
                              (iii) Appropriate conditions for the
                            monitoring and reporting of adverse
                            events associated with the emergency
                            use of the product.
                              (iv) For manufacturers of the
                            product, appropriate conditions
                            concerning recordkeeping and reporting,
                            including records access by the
                            Secretary, with respect to the
                            emergency use of the product.
                      (B) Authority for additional conditions.--
                    With respect to the emergency use of an
                    unapproved product, the Secretary, to the
                    extent feasible given the circumstances of the
                    emergency, may, for persons who choose to carry
                    out one or more activities for which the
                    authorization is issued, establish such
                    conditions on an authorization under this
                    section as the Secretary finds necessary or
                    appropriate to protect the public health,
                    including the following:
                              (i) Appropriate conditions on which
                            entities may distribute the product
                            with respect to the emergency use of
                            the product (including limitation to
                            distribution by government entities),
                            and on how distribution is to be
                            performed.
                              (ii) Appropriate conditions on who
                            may administer the product with respect
                            to the emergency use of the product,
                            and on the categories of individuals to
                            whom, and the circumstances under
                            which, the product may be administered
                            with respect to such use.
                              (iii) For persons other than
                            manufacturers of the product,
                            appropriate conditions concerning
                            recordkeeping and reporting, including
                            records access by the Secretary, with
                            respect to the emergency use of the
                            product.
                              (iv) With respect to the emergency
                            use of the product, waive or limit, to
                            the extent appropriate given the
                            circumstances of the emergency,
                            conditions regarding current good
                            manufacturing practice otherwise
                            applicable to the manufacture,
                            processing, packing, or holding of
                            products subject to regulation under
                            this Act, including such requirements
                            established in section 501.
              (2) Unapproved use.--With respect to the emergency
            use of a product that is an unapproved use of an
            approved product:
                      (A) The Secretary may, for manufacturers of
                    the product who choose to carry out one or more
                    activities for which the authorization is
                    issued, establish any of the conditions
                    described in clauses (i) through (iv) of
                    paragraph (1)(A).
                      (B)(i) If the authorization under this
                    section regarding the emergency use authorizes
                    a change in the labeling of the product, but
                    the manufacturer of the product chooses not to
                    make such change, such authorization may not
                    authorize distributors of the product or any
                    other person to alter or obscure the labeling
                    provided by the manufacturer.
                      (ii) In the circumstances described in clause
                    (i), an authorization under this section
                    regarding the emergency use may, for persons
                    who do not manufacture the product and who
                    choose to act under this clause, authorize such
                    persons to provide information on the product
                    in addition to the labeling provided by the
                    manufacturer, subject to compliance with clause
                    (i). Such additional information shall not be
                    considered labeling for purposes of section
                    502.
      (f) Duration of Authorization.--
              (1) In general.--Except as provided in paragraph (2),
            an authorization under this section shall be effective
            until the earlier of the termination of the declaration
            under subsection (b) or a revocation under subsection
            (g).
              (2) Continued use after end of effective period.--An
            authorization shall continue to be effective for
            continued use with respect to patients to whom it was
            administered during the period described by paragraph
            (1), to the extent found necessary by such patients'
            attending physicians.
      (g) Revocation of Authorization.--
              (1) Review.--The Secretary shall periodically review
            the circumstances and the appropriateness of an
            authorization under this section.
              (2) Revocation.--The Secretary may revoke an
            authorization under this section if, in the Secretary's
            unreviewable discretion, the criteria under subsection
            (c) for issuance of such authorization are no longer
            met.
      (h) Publication.--The Secretary shall promptly publish in the
    Federal Register a notice of each authorization, and each
    termination or revocation of an authorization, and an
    explanation of the reasons therefor, under this section.
      (i) Actions Committed to Agency Discretion.--Actions under
    the authority of this section by the Secretary, by the
    Secretary of Defense, or by the Secretary of Homeland Security
    are committed to agency discretion.
      (j) Rules of Construction.--Nothing in this section shall be
    construed to impair or otherwise affect--
              (1) the authority of the President as Commander in
            Chief of the Armed Forces of the United States under
            article II, section 2 of the United States
            Constitution;
              (2) the authority of the Secretary of Defense with
            respect to the Department of Defense, including the
            armed forces, under other provisions of Federal law; or
              (3) the authority of the Secretary under section
            319F-2 to manage the stockpile under such section.
      (k) Application to Members of Armed Forces.--
              (1) Waiver of requirement relating to option to
            refuse.--In the case of administration of a
            countermeasure to members of the armed forces, a
            requirement, under subsection (e)(1)(A)(ii)(III),
            designed to ensure that individuals are informed of an
            option to accept or refuse administration of a product,
            may be waived by the President if the President
            determines, in writing, that complying with such
            requirement is not feasible, is contrary to the best
            interests of the members affected, or is not in the
            interests of national security.
              (2) Provision of information to member of the armed
            forces.--If the Secretary makes a determination that it
            is not feasible for the information required by
            subsection (e)(1)(A)(ii) to be provided to a member of
            the armed forces prior to the administration of the
            product, such information shall be provided to such
            member of the armed forces (or next-of-kin in the case
            of the death of a member) to whom the product was
            administered as soon as possible, but not later than 30
            days, after such administration. Information concerning
            the administration of the product shall be recorded in
            the medical record of the member.
              (3) Effect on statute pertaining to investigational
            new drugs.--In the case of an authorization based on a
            determination by the Secretary of Defense under
            subsection (b)(1)(B), section 1107 of title 10, United
            States Code, shall not apply to use of a product that
            is the subject of such authorization, within the scope
            of such authorization and while such authorization is
            effective.
      (l) Relation to Other Provisions.--If a product is the
    subject of an authorization under this section, the use of such
    product within the scope of the authorization --
              (1) shall not be subject to any requirements pursuant
            to section 505(i) or 520(g); and
              (2) shall not be subject to any requirements
            otherwise applicable to clinical investigations
            pursuant to other provisions of this Act.
      (m) Discretion Regarding Use of Authorization.--Nothing in
    this section provides the Secretary any authority to require
    any person to carry out any activity that becomes lawful
    pursuant to an authorization under this section, and no person
    is required to inform the Secretary that the person will not be
    carrying out such activity, except that a manufacturer of a
    sole-source unapproved product authorized for emergency use
    shall notify the Secretary within a reasonable period of time
    after the issuance by the Secretary of such authorization if
    such manufacturer does not intend to carry out an activity or
    activities under the authorization. This section does not have
    any legal effect on a person who does not carry out any
    activity for which an authorization under this section is
    issued, or who carries out such an activity pursuant to other
    provisions of this Act or section 351 of the Public Health
    Service Act.
      (n) Enforcement.--A person who carries out an activity
    pursuant to an authorization under this section, but who fails
    to comply with applicable conditions under subsection (e), is
    with respect to that act of noncompliance subject to the
    provisions of law specified in subsection (a) and to the
    enforcement of such provisions under section 301.